BIOTRONIK LEAD LIMITED WARRANTY
This Limited Warranty provides specific legal rights to any patient who receives a BIOTRONIK
implantable lead.
Subject to the limitations of this warranty, BIOTRONIK leads are free from manufacturing defects
in materials and workmanship. Should replacement be required due to device malfunction,
BIOTRONIK will extend FULL CREDIT EQUAL TO THE ORIGINAL PURCHASE PRICE against
a BIOTRONIK lead purchased for replacement. In addition, up to $600 will be paid directly to the
patient for surgical fees and hospital expenses incidental to replacement surgery, which are not
reimbursed by any third party. BIOTRONIK’s obligation to pay reasonable uninsured medical
expenses shall be limited to $600 even if both the lead and the pacemaker / ICD are replaced.
To qualify for the Limited Lead Warranty, the following terms must be met:
1)
The lead was stored and handled within specifications and implanted prior
to the “use before" date.
2)
The explanted lead was returned to BIOTRONIK for testing and was
replaced with another BIOTRONIK lead. All documentation or threshold
readings detailing failure to function within normal tolerances are to be
enclosed with the returned lead.
This lead warranty is limited to the terms defined herein and applies only to the patient who
receives a BIOTRONIK lead containing this warranty claim. Implantable leads are part of the
interdependent pacemaker or ICD system chosen by a physician according to the patient's
physiological environment. Because of differences in the physical condition of patients, no
representation or warranty is made that the body will not react adversely to any part of this
treatment.
EXCEPT AS EXPRESSLY PROVIDED BY THIS WARRANTY, NEITHER BIOTRONIK NOR ITS
REPRESENTATIVE(S) IS RESPONSIBLE FOR ANY DAMAGE OR INJURY DUE TO DEFECT
OR MALFUNCTION OF THE LEAD, WHETHER THE CLAIM IS BASED ON WARRANTY,
CONTRACT, TORT OR OTHERWISE. NO WARRANTY IS MADE, EXPRESS OR IMPLIED, AS
TO THE PERFORMANCE OR LIFE OF THIS IMPLANTABLE LEAD, WHETHER OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR USE, OR OTHERWISE. SOME STATES
DO NOT ALLOW LIMITATION ON HOW LONG AN IMPLIED WARRANTY LASTS, OR THE
EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES;
THEREFORE, THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO THE
PATIENT.
This warranty is offered for implantable BIOTRONIK leads sold in the United States only. The
patient may also have other legal rights which may vary from state to state.
BIOTRONIK, Inc.
6024 Jean Road
Lake Oswego, OR 97035-5369
(800) 547-0394
W4003-D 5/07