Pacemaker Troubleshooting
Module 9
1
Objectives
• List steps in performing troubleshooting
• Correctly identify the following on an ECG strip:
– Pacemaker ERI behavior
– Loss of Capture
– Over- and undersensing
– Magnet behavior
– Pseudo-malfunctions
• Make clinically appropriate suggestions based on
interpretation
– Identify additional information or other resources useful to
diagnosing pacemaker malfunction
2
Some Good Advice
• Perform all troubleshooting and all pacemaker checks the
same way
– Collect the data
– Ask questions
– Keep an open mind
– Analyze, form hypothesis, test
– Don’t make assumptions
• The simplest explanation that covers all the facts, is usually
the correct explanation
3
The Four Solutions to Pacemaker Problems
• Re-Program – the device
• Re-Place – the system or a component
• Re-Position – the lead(s), the device
• Retreat – do nothing, because nothing is wrong
4
The Process
• Observe/collect data
– Measure the ECG (e.g., A-A, V-V, A-V, V-A)
• Form your hypothesis
• Test your “solution”
• Make a suggestion
– Ask the clinician questions
5
Data Sources
• Programmed parameters
• Device model number
• Patient symptoms
• Lead model numbers
• Medical history
• Telemetry data
• Indication for implant
– Impedances
• Implant date
– Battery voltage
• Rhythm strip
– Marker Channel™
• Device diagnostics
• Device RRT and EOS behaviors
6
Case 1
• Information you have:
– DDD 60-130
Click for Hint
– PAV/SAV 150-120 ms
– PVARP 310 ms
• Question: Why is rhythm irregular, sometimes fast?
– Hypotheses:
• Tracking PAF
• Oversensing (tracking a “P-wave” that is not there)
• Are these grouped beats – upper tracking rate behavior?
7
Case 1
First Hypothesis: Tracking Paroxysmal AF
• What is the evidence for AF?
– Irregular ventricular events
– Could be “fine” AF, not visible on baseline
• What is the evidence against AF?
– Some visible P-waves
– Evidence of atrial pacing
8
Case 1
Second Hypothesis: Atrial Oversensing
• What is the evidence for atrial oversensing?
– Irregular ventricular tracking
– Evidence of ventricular tracking without visible P-waves
• What is evidence against atrial oversensing?
– There may be P-waves “hidden” in some T-waves
9
Case 1
Third Hypothesis: Upper Rate Behavior
• What is the evidence for Wenckebach?
– Some evidence of “grouped” beats
– Evidence of P-waves “hidden” in some T-waves
• What is evidence against Wenckebach?
– The A-A intervals don’t march out
– Evidence of atrial pacing – no need if this is UTR behavior
10
Case 1
What Are Your Next Steps?
• To form a better hypothesis:
– Interrogate pacemaker
– Observe ECG and Marker Channel strip
• To test the hypothesis:
– Perform sensing test – observe rhythm/markers
– Check lead impedance for low impedance (insulation break), which
often causes oversensing (< about 250 Ω)
• What is the normal impedance range (assume standard leads)?
11
Case 1
Final Hypothesis: Arial Oversensing
• Confirmed by
– Marker Channel annotations showing AS markers without P-waves
12
Case 1
Conclusion: Arial Oversensing
• What do you consider?
– The “service” you provide to the customer is not in just interpreting
pacemaker behavior
– You are there to supplement the customer’s clinical knowledge and
experience with your knowledge and experience regarding the
pacing system
– If the customer asks, you have to be ready to make an appropriate
suggestion
• Ask questions
• Find out the relevant concerns that the customer has for this patient
• If you are uncertain, call Technical Services
13
Example Case 1
Conclusion: Arial Oversensing
• Cause
– Insulation breach
– Bipolar impedance: 190 Ω
14
Example Case 1
Conclusion: Artial Oversensing
• Considerations:
– How easy is it to “fix”
• Unipolar lead in situ
– What are the risks to the patient to “fix”
• Elderly, debilitated patient
– What are the risks/implications if it is not “fixed”
• Loss of AV synchrony
• Possible that AF diagnostics are not accurate
• Risk of PMT
– Are there any alternatives?
• VVI?
15
Example Case 1
Conclusion: Arial Oversensing
• Cause
– Unknown
• Other resources
– Medtronic Technical Services
• 1 800 505 4636 (within the U.S.)
– Medtronic Product Performance Report
• There may be an issue with a particular Medtronic product you
are not aware of
• Other manufacturers do not necessarily produce these reports
– Your colleagues
16
Case 2
• Programming information:
– DDD 60–130 bpm
– PAV: 150 ms
– SAV: 120 ms
– PVARP: 310 ms
17
Case 2
Hypothesis
Loss of Capture
Click for Answer
– Idioventricular rate is masquerading as a “capture/pseudo-fusion”
To test hypothesis:
Click for Answer
- Perform a threshold test
18
Case 2
Considerations
• Causes
• Considerations
– If there were changes in
medications, or an MI, or the
patient had renal failure, etc. ?
– Program a higher output for an
increased safety margin, as
conditions are changing
– If chronic lead impedance is
high?
– Suspect fracture. Could try
unipolar temporarily, but this will
likely require a lead
replacement.
– If lead impedance is ok?
– Suspect dislodgement. Can try
a higher output, but permanent
fix will likely be repositioning.
– If acute lead impedance is high?
– Likely a loose set screw. Need
to re-open the pocket and
retighten it.
Click for Answers
19
Case 3
• Programming information
– DDD 60–120 bpm
– PAV: 150 ms
– SAV: 120 ms
– PVARP: 380 ms
20
Case 3
Hypothesis: Pacemaker Wenckebach
• Upper rate behavior
Click for Answer
– Is this evidence of “grouped beats?”
– Do we see regular atrial activity with increasing A-V intervals?
• Intermittent atrial undersensing
– Do the pauses occur because a P-wave is not sensed, and thus,
not tracked?
21
Case 3
Hypothesis: Pacemaker Wenckebach
• How do you test this hypothesis?
Click for Answer
– Knowing what the patient was doing when this occurred is helpful.
For example, this strip was collected while the patient was on a
treadmill (exercising).
– Analyze the strip:
• The regularity of the increasing A-V intervals is obvious
• The regularity of the grouped beats is suggestive
– What other hypotheses are there? For example, intermittent atrial
undersensing might look like this – test for these as well.
– If possible, recreate the conditions
– Finally, what is TARP? What are the atrial intervals? Is pacemaker
Wenckebach possible?
22
Case 3
Hypothesis: Pacemaker Wenckebach
• Considerations
Click for Answer
– Is this really a problem?
• The pacemaker is behaving normally
– What to consider if the patient’s ADL’s are compromised?
• Pacer Wenckebach occurs when the atrial rate increases and approaches the 2:1
block point
• Recall from the Timing Modules that (SAV + PVARP) = TARP, so we:
– Can increase the UTR
– And decrease TARP by:
» Less PVARP
» Less AV – use Rate Adaptive AV
» Use Auto-PVARP options
23
Case 4
• Your information:
– DDD 60–130 bpm
– PAV: 150 ms
– SAV: 120 ms
– PVARP: 310 ms
24
Case 4
Hypothesis
• What explains this atrial pace?
Click for Answer
– Intermittent atrial undersensing. The P-wave was not “seen”
and the lower rate (LRL) timed out, resulting in an atrial pace
• Review question:
Click for Answer
– Why did this atrial pace NOT capture? (Hint: Think of the
ECG module.)
• Because the atrial pacing occurred in the absolute refractory
period of the atrial muscle tissue
25
Case 4
Confirming Your Hypothesis
• What would you do?
• Interrogate and observe
the rhythm
• What would you expect to
see?
• P-waves without markers
Click for Answers
26
Case 4
Testing Your Hypothesis
• What would you do to test
your hypothesis?
Click for Answers
• Perform a sensing test
– Is the device programmed
correctly?
– P/R- wave amplitudes can
change
• Check Lead Impedances
– Undersensing can be a symptom
of a lead fracture or lead
insulation failure
– Undersensing can be a symptom
of lead dislodgement
27
Case 4
Considerations
• Suppose the device were
programmed to 4.0 mV atrial
sensitivity, and the P-waves
measure 4.0- 5.0 mV. Would
programming a sensing value of
2.0 mV make it more or less
sensitive?
• Would you choose 2.0 mV or a
value even more sensitive if the
device operations remained
normal? Why?
• 2.0 mV is more sensitive than
4.0 mV
Click for Answers
• Program to a more sensitive
value to make sure the device
can sense AF, for example
28
One Consequence of Atrial Undersensing
• Programming information:
– DDD 60–120 bpm
– PAC: 150 ms
– SAV: 120 ms
– PVARP: 310 ms
• PMT (pacemaker mediated tachycardia) caused by atrial
undersensing and retrograde conduction
• The abrupt onset is one hallmark of PMT
29
PMT
Pacemaker Mediated Tachycardia
• Occurrence minimized with introduction of Auto-PVARP or
dynamic TARP operations
– Which provide longer pacemaker atrial refractory periods at lower
rates
• PMT is similar to a re-entrant tachycardia discussed in
Module 1
– Except the pacemaker forms part of the re-entrant circuit
30
PMT Mechanism
• A ventricular event occurs
– Paced or sensed – we show a PVC
here
• Conducts retrograde through the AV
node (typically)
• And results in an atrial sense
– Which starts an SAV, and results in a
ventricular pace
• This is again conducted retrograde,
and the sequence starts again
– VP, which goes retrograde V-A,
resulting in an AS starting an SAV,
resulting in a…VP which goes retrograde V-A
resulting in an AS starting an SAV resulting in a…
VP which goes retrograde V-A resulting in an AS starting an
SAV resulting in a… VP which goes retrograde V-A resulting in an AS
starting an SAV resulting in a…
– You get the idea
31
PMT Requirements
• For the sequence to be
maintained:
– The AV node and atrium must be
able to conduct retrograde, i.e.,
not be depolarized
– The pacemaker must be able to
sense this retrograde
depolarization, i.e., not be in a
refractory period
– This timing ‘ballet’ must persist
32
Case 5
Hypotheses
• Is this PMT?
Click for Answers
• Is this simply the pacemaker tracking a sinus tachycardia?
– DDD 60-120 PAC/SAV 150-120 ms, PVARP 310 ms
• What was the patient doing when this occurred?
• If exercising, it may favor tracking
• If at rest, be suspicious of PMT
33
Case 5
Confirming Your Hypotheses
Click for Answers
• Place a magnet on the device
during the tachycardia. What
happens?
• A magnet makes the pacemaker
DOO
• If this is PMT, what would you
expect to see?
• PMT requires atrial sensing
• If this is tracking, what would you
expect to see?
• Evidence of atrial tachycardia
during asynchronous operation
– DOO suspends the pacemaker’s
sensing function, so the PMT
breaks
34
Case 5
Confirming Your Hypotheses
• Place a magnet on the device
• DOO suspends sensing and the tachycardia terminates
• No evidence of atrial tachycardia during the asynchronous
operation
35
Case 5
Considerations
• The AV node and atrium must
be able to conduct retrograde
(i.e., not be depolarized)
• Typical causes
– Loss of atrial capture
– Loss of atrial sensing (atrial
undersensing)
– Atrial oversensing
• The pacemaker must be able
to sense this retrograde
depolarization (i.e., atrial
event falling outside of a
refractory period)
– PVC with retrograde
conduction/accessory pathway
• Typical causes
– PVARP too short
– Auto-PVARP not in use
– PVC Response not in use
36
Addressing PMT
• Test
– Atrial output threshold
– Atrial sensing test
– Retrograde conduction
• To fix
– Reprogram the pacemaker outputs as needed
– Increase PVARP to make the retrograde atrial event an AR
• Turn PMT Intervention “On”
• Turn PVC Response “On”
– Rarely, may need to reposition a lead or ablate a pathway
37
Solution: PVC Response
• Designed to prevent sensing of retrograde P-waves, when
they happen due to a PVC
38
Solution: PMT Intervention
• Designed to interrupt a Pacemaker-Mediated Tachycardia
DDD / 60 / 120
39
Case 6
• Programming information
Click for Hint
– DDD 60–130 bpm
– PAV: 150 ms
– SAV: 120 ms
– PVARP: 320 ms
• Any hypotheses?
– Atrial undersensing
– Ventricular oversensing
40
Case 6
Hypothesis: Atrial Undersensing
X
• If this P-wave is not sensed, and not tracked, then determine when the
next atrial event should occur in the timing sequence
• DDD 60 (1000 ms) minus the SAV (120 ms) = 880 ms from the last
QRS to the next atrial pace (the V-A interval). We should see an atrial
pace at the X.
• Thus, this cannot be atrial undersensing
41
Case 6
Hypothesis: Ventricular Oversensing
• Remember the information
– A-A = 1000 ms
– PVARP 320 ms
– Calculated the V-A = 880 ms
– A-V = 120 ms
A
R
V
S
Measure the V-A interval from the atrial pace, and assume the pacemaker
sensed a ventricular “event” here.
The atrial event then fell in the PVARP of this “event” – and can not be used
for timing, thus it did not start an SAV.
42
Case 6
Confirming the Hypothesis: Ventricular Oversensing
Click for Answers
• What would you do?
• Interrogate and observe the rhythm
• What would you expect to see?
• VS/VR markers without QRS
complexes
43
Case 6
Confirming the Hypothesis: Ventricular Oversensing
• But suppose you interrogate and consistently get this strip.
What next?
Click for Answers
– Run a sensing test anyway
– Try to provoke oversensing
– Program to non-RR mode
• Arm/shoulder movement
• Have patient reach across
his/her body
• Observe Marker Channel for
VS without a QRS
– More common with
unipolar sensing
44
Review Questions
Click for Answers
• What patient complaints might you suspect with this strip?
• What pacemaker telemetry data might indicate the cause?
• What long-term effect will this condition have on device
diagnostics?
• C/O syncope, presyncope, vertigo,
weakness…
• Ventricular lead impedance
• Ventricular rate diagnostics
inaccurate because of this
oversensing – may be interpreted
as arrhythmia
45
A Little Advice…
• When you see evidence of “over pacing” i.e., pacing
despite intrinsic activity
– Consider undersensing
– See Case 4
• When you see evidence of “under-pacing” i.e., pauses
without pacing
– Consider oversensing
– See Case 6
• These rules are NOT absolute
46
Case 7
No Programmer Available
Questions to ask yourself:
Clickforfor
Hints
Click
Answers
• Is this a single chamber VVI pacemaker?
• If it is dual chamber, is it tracking?
– But if it is tracking what would cause AV intervals to change?
• If it is not tracking, e.g.,
because of atrial undersensing,
what causes the V pacing?
• Can’t be VVI, see A-V pacing.
Must be dual-chamber device
• Hard to believe this is
tracking with these AV
intervals, and it can’t be
Wenckebach at this rate
• Good question!
47
Case 7
No Programmer Available
Questions to ask yourself:
• What kind of pacemaker:
– Paces in the atrium and ventricle
– Senses in the atrium and
ventricle
– But does NOT track?
• The simplest answer that
explains all the facts, is
likely the correct answer.
Click for Answers
• How about DDI(R)
– The response to sensing is to
inhibit
– No SAV can be initiated
– Without an AP, the ventricle is
paced at the lower rate
– If after a V-A interval, there is no
AS, then an AP and a PAV
Click for Hints
48
Case 7
Review Questions
Click for Answers
• What is the underlying rhythm?
• Is the pacing mode appropriate
for this rhythm?
• What would be a better choice?
• It appears to be Complete Heart
Block
– No evidence of AV synchrony
• DDIR? No
• DDD or even VDD
• Why?
• It looks like the atrium is reliable
49
Case 8
No Programmer Available
• Patient is in the hospital on bed rest
• Admitted for non-cardiac problem
– Medical record indicates he has a dual chamber pacemaker
A physician hands you this and says, ”I think he is
having PMT, what is your opinion?”
50
Case 8
No Programmer Available: Hypotheses
• Is this PMT?
• No, PMT requires tracking – this
shows atrial pacing
• If not PMT, what would cause
atrial pacing at this rate (which
is…?)
• Atrial rate of about 100 bpm
• How can it be Rate Response –
he is at rest?
• Rate Response could be
programmed too aggressively. It
might be an MV sensor, and he is
having a fever or an anxiety attack…
Click for Answers
– Could be Rate Reponse pacing
– Or a special pacemaker intervention
51
Case 8
No Programmer Available: Confirming the Hypothesis
• What resources are
available to you?
– Medical Record and Nurse
– Office pacemaker chart
– Technical Services
– Patient
Click for Answers
• What information would
you look for?
– Mode of pacemaker
• Patient vital signs/activity
– Model
– Last programmed values
– Indication
– Interpretation/Confirmation of
the ECG strip
• Other explanations
– What were you doing?
52
Case 9
• Programming
information
– DDDR 60-130 bpm
– PAV: 150 ms
– SAV 120 ms
– PVARP: Auto
• How can there be pacing and
sensing at less than the lower
rate?
• Is this pacemaker
malfunctioning?
Atrial Rate Histogram
– No other therapies or
unusual programming
options chosen
53
Case 9
Hypotheses
• Phenomena:
– The device pace appears to be operating at less than the lower rate
• Hypotheses:
– There are special programming options that could affect the
histogram producing these results
• Hysteresis
• Sleep Function
– The device is actually programmed to a lower rate of 40 bpm
– The programming information is correct, so the device is
malfunctioning
54
Case 9
Why is the Pacemaker Altering the Lower Rate?
• Interrogation confirms:
– Programming information is correct
– DDDR 60-130 bpm, PAV/SAV 150/120 ms, PVARP-Auto
– Hysteresis and Sleep Function: Off
Click for Hint
Recall from Module 7:
Normally, pacemakers use A-A timing to maintain a steady atrial rate.
V-V timing is used only under some special circumstances. This is an
example of the effect the change in fundamental timing has on the
pacemaker.
55
Case 9
• Basic IPG timing is A-A, but after a (pacemaker-defined)
PVC, it switches to V-V timing
1600ms
DDDR 60/130
• This maintains a stable V-V interval (at the lower or sensor
indicated rate, whichever is faster and depending on the
mode)
• The resulting AS-AP interval may exceed LRL and is noted
in the histogram
56
Case 9
Considerations
• Is the pacemaker
malfunctioning?
• No, this is normal pacemaker
behavior
• Is the patient symptomatic with
this pacemaker operation?
• Unlikely, as the ventricular rate is
relatively stable
• What do you suggest?
• The pacemaker is implanted in
order to address patient
symptoms. Concentrate on the
patient, not on the diagnostic.
Click for Answers
57
Recap
The Four Solutions to Pacemaker Problems
• Re-Program – the device
• Re-Place – the system or a component
• Re-Position – the lead(s), the device
• Retreat – do nothing, because nothing is wrong
So….
• Observe/Collect data
• Measure (e.g., A-A, V-V, A-V, V-A)
• Form your hypothesis
• Test your “solution”
• Make a suggestion
58
Final Nugget
• Most pacemaker “malfunctions” can be explained by:
– Dislodged leads or failing leads
– Battery end-of-life
– Inappropriate programming due to
• Changing patient conditions
• An error
– Normal operations you do not fully understand
• Sudden changes in timing are almost always normal
pacemaker (if advanced) operations
59
Brief Statements
Indications
•
Implantable Pulse Generators (IPGs) are indicated for rate adaptive pacing in patients who ay benefit from increased
pacing rates concurrent with increases in activity and increases in activity and/or minute ventilation. Pacemakers are
also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV
synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration
of both rate and AV synchrony, which include various degrees of AV block to maintain the atrial contribution to cardiac
output and VVI intolerance (e.g. pacemaker syndrome) in the presence of persistent sinus rhythm.
•
Implantable cardioverter defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular
defibrillation for automated treatment of life-threatening ventricular arrhythmias.
•
Cardiac Resynchronization Therapy (CRT) ICDs are indicated for ventricular antitachycardia pacing and ventricular
defibrillation for automated treatment of life-threatening ventricular arrhythmias and for the reduction of the symptoms of
moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite
stable, optimal medical therapy and have a left ventricular ejection fraction less than or equal to 35% and a QRS
duration of ≥130 ms.
•
CRT IPGs are indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class
III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular
ejection fraction less than or equal to 35% and a QRS duration of ≥130 ms.
Contraindications
•
IPGs and CRT IPGs are contraindicated for dual chamber atrial pacing in patients with chronic refractory atrial
tachyarrhythmias; asynchronous pacing in the presence (or likelihood) of competitive paced and intrinsic rhythms;
unipolar pacing for patients with an implanted cardioverter defibrillator because it may cause unwanted delivery or
inhibition of ICD therapy; and certain IPGs are contraindicated for use with epicardial leads and with abdominal
implantation.
•
ICDs and CRT ICDs are contraindicated in patients whose ventricular tachyarrhythmias may have transient or
reversible causes, patients with incessant VT or VF, and for patients who have a unipolar pacemaker. ICDs are also
contraindicated for patients whose primary disorder is bradyarrhythmia.
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Brief Statements (continued)
Warnings/Precautions
• Changes in a patient’s disease and/or medications may alter the efficacy of the device’s programmed
parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid
possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an
arrhythmia, device electrical reset or device damage. Do not place transthoracic defibrillation paddles
directly over the device. Additionally, for CRT ICDs and CRT IPGs, certain programming and device
operations may not provide cardiac resynchronization. Also for CRT IPGs, Elective Replacement
Indicator (ERI) results in the device switching to VVI pacing at 65 ppm. In this mode, patients may
experience loss of cardiac resynchronization therapy and / or loss of AV synchrony. For this reason,
the device should be replaced prior to ERI being set.
Potential complications
• Potential complications include, but are not limited to, rejection phenomena, erosion through the skin,
muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, and
surgical complications such as hematoma, infection, inflammation, and thrombosis. An additional
complication for ICDs and CRT ICDs is the acceleration of ventricular tachycardia.
• See the device manual for detailed information regarding the implant procedure, indications,
contraindications, warnings, precautions, and potential complications/adverse events. For further
information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at
www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
61
Brief Statement: Medtronic Leads
Indications
• Medtronic leads are used as part of a cardiac rhythm disease management system. Leads are
intended for pacing and sensing and/or defibrillation. Defibrillation leads have application for patients
for whom implantable cardioverter defibrillation is indicated
Contraindications
• Medtronic leads are contraindicated for the following:
• ventricular use in patients with tricuspid valvular disease or a tricuspid mechanical heart valve.
• patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate or dexamethasone
acetate may be contraindicated. (includes all leads which contain these steroids)
• Epicardial leads should not be used on patients with a heavily infracted or fibrotic myocardium.
• The SelectSecure Model 3830 Lead is also contraindicated for the following:
• patients for whom a single dose of 40.µg of beclomethasone dipropionate may be contraindicated.
• patients with obstructed or inadequate vasculature for intravenous catheterization.
62
Brief Statement: Medtronic Leads (continued)
Warnings/Precautions
• People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), and
accompanying leads should not receive diathermy treatment. The interaction between the implant and
diathermy can cause tissue damage, fibrillation, or damage to the device components, which could
result in serious injury, loss of therapy, or the need to reprogram or replace the device.
• For the SelectSecure Model 3830 lead, total patient exposure to beclomethasone 17,21-dipropionate
should be considered when implanting multiple leads. No drug interactions with inhaled
beclomethasone 17,21-dipropionate have been described. Drug interactions of beclomethasone
17,21-dipropionate with the Model 3830 lead have not been studied.
Potential Complications
• Potential complications include, but are not limited to, valve damage, fibrillation and other arrhythmias,
thrombosis, thrombotic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade,
muscle or nerve stimulation, pericardial rub, infection, myocardial irritability, and pneumothorax.
Other potential complications related to the lead may include lead dislodgement, lead conductor
fracture, insulation failure, threshold elevation or exit block.
• See specific device manual for detailed information regarding the implant procedure, indications,
contraindications, warnings, precautions, and potential complications/adverse events. For further
information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at
www.medtronic.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
63
Disclosure
NOTE:
This presentation is provided for general educational purposes
only and should not be considered the exclusive source for this
type of information. At all times, it is the professional
responsibility of the practitioner to exercise independent
clinical judgment in a particular situation.
64