Non-Rechargeable Implantable Pulse Generator (Ipg) - Boston Scientific Vercise Mode D'emploi

Non‑Rechargeable Implantable Pulse Generator (IPG)
Boston Scientific Corporation warrants to the patient who receives an implantable non‑rechargeable
pulse generator (referred to as the Non‑Rechargeable IPG) that the Non‑Rechargeable IPG will
be free from defects in workmanship and materials for a period of two (2) years from the date of
surgical implant of the Non‑Rechargeable IPG. This warranty applies only to the patient who has the
Non‑Rechargeable IPG implanted and no other person or entity. This warranty does not apply to the
leads, extensions, or surgical accessories used with the Non‑Rechargeable IPG.
A Non‑Rechargeable IPG that fails to function within normal ranges within two (2) years after the date
it is implanted is covered under this Limited Warranty. The liability of Boston Scientific under this
warranty shall be limited to: (a) replacement of the Non‑Rechargeable IPG with a functionally equivalent
Non‑Rechargeable IPG made by Boston Scientific; or (b) credit applied towards the purchase of a new
IPG. The warranty amount is calculated using least expensive device price (original vs. replacement).
No other relief whatsoever is available under this limited warranty. This limited warranty for a
replacement Non‑Rechargeable IPG will last only for two years from the date of surgical implant of the
original Non‑Rechargeable IPG.
Battery life of a Non‑Rechargeable IPG may vary due to a variety of factors. Therefore,
Note:
this warranty shall not extend to battery depletion of a Non‑Rechargeable IPG unless such
depletion is caused by a defect in workmanship or material. Battery life is dependent on your
stimulation settings and conditions.
Claims under this limited warranty are subject to the following additional conditions and limitations:
1. The Product Registration Form/Implant Card must be completed and returned to Boston Scientific
within 30 days of surgery.
2. The Non‑Rechargeable IPG must be implanted before the "Use By" date.
3. Failure of the Non‑Rechargeable IPG must be confirmed by Boston Scientific.
4. The Non‑Rechargeable IPG must be returned to Boston Scientific (or a Boston Scientific authorized
agent) within 30 days after it fails to function within normal ranges. That Non‑Rechargeable IPG will
be the property of Boston Scientific.
5. The limited warranty does not include failures to function within normal ranges caused by:
(a). Fire, floods, lightning, natural disasters, water damage, and other calamities commonly defined
as "Acts of God";
(b). Accident, misuse, abuse, negligence, or the customer's failure to operate the
Non‑Rechargeable IPG in accordance with manufacturer's instructions;
(c). Unauthorized attempts to repair, maintain, or modify the Non‑Rechargeable IPG for the patient
or any unauthorized third party; or
(d). Attaching equipment to the Non‑Rechargeable IPG that is not supplied or expressly authorized
by Boston Scientific.
This limited warranty is the only warranty that applies to the Non‑Rechargeable IPG, and
Boston Scientific expressly disclaims any other warranty, express or implied, including any warranty
of merchantability or fitness for a particular purpose. Under this limited warranty, Boston Scientific
will be responsible only for replacement of the Non‑Rechargeable IPG with a functionally equivalent
Non‑Rechargeable IPG made by Boston Scientific and will not be liable for any damages (whether direct,
indirect, consequential,or incidental) caused by the Non‑Rechargeable IPG, whether the claim is based
on warranty, contract, tort or any other theory.
Boston Scientific assumes no liability with respect to instruments reused, reprocessed or resterilized
and makes no warranties, express or implied, including but not limited to merchantability or fitness for a
particular purpose, with respect to such instruments.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
Limited Warranty - IPGs
92328649-04 31 of 149