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Appendix
Disclaimer
Conditions of use and
requirements
Implantable BIOTRONIK leads (called "leads" in the following) are sophisticated,
precision mechanical medical products.
They should be as thin and flexible as possible.
After implantation, they are subjected to great stress due to the mobilization of the
immune defense of the human organism.
Although they are designed to function reliably for many years under the given
conditions, their resilience and durability are limited.
Risks and possible
complications
Problems or failures that occur during or after lead implantation can have many
causes.
For example:
•
Medical complications
•
Foreign body rejection phenomena
•
Fibrosis
•
Lead dislodgement
•
Erosion
•
Migration through body tissue
•
Insulation defect
Risk of damage
Despite meticulous care in development, material selection, production, and final
inspection prior to delivery, leads can be easily damaged in the event of improper
handling or use.
Limitation of liability
BIOTRONIK does not guarantee that the following events will not occur:
•
Lead malfunctions or failures
•
Defense reactions of the body against lead implantation
•
Medical complications (including myocardial perforation) during lead
implantation or as a consequence of implanting the lead
The same applies to implantation and lead accessories by BIOTRONIK.
Burden of proof for defective
goods
The state of the product at the time of sale is critical for any product returns.
No liability is assumed for any defects not immediately detected upon receipt of the
goods.
Responsibility for
complications and
consequential damage
The buyer/user bears the entire risk associated with the use of the lead.
BIOTRONIK shall not be liable for any loss, damage, or injury of any nature, whether
direct, indirect, or consequential, that may occur in connection with the leads and
accessories or their use.
BIOTRONIK shall not reimburse the customer or a third party for any costs incurred
in connection with the use, malfunction, or failure of any lead or accessory,
including physician's fees, hospital expenses, medication costs, subsidiary costs,
and costs for consequential damages.
Final clause
No one is authorized to hold BIOTRONIK liable for any statement or warranty
deviating from the above.
