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Device Lifetime
The minimum lifetime of the implantable components is 5 years. However, the non‑rechargeable
IPG may have less than 5 years of lifetime depending on the stimulation settings and conditions.
See the "Non‑Rechargeable Stimulator Battery" section of this manual for more information about
the non-rechargeable stimulator battery.
Contraindications
The Boston Scientific DBS System, or any of its components, is contraindicated for the following:
Diathermy: Shortwave, microwave, and/or therapeutic ultrasound diathermy should not be used
on patients implanted with the Boston Scientific DBS System, or any of the system components.
The energy generated by diathermy can be transferred to the Boston Scientific DBS System,
causing tissue damage at the contact site resulting in severe injury or death.
Magnetic Resonance Imaging (MRI) (Vercise PC Only): Patients implanted with the
Vercise PC DBS System (DBS Leads, Lead Extensions, and Stimulator) should not be subjected to
MRI. MRI exposure may result in the following:
•
Dislodgement of implanted components.
•
Heating of the Contacts or other system components, causing permanent tissue
lesioning.
•
Damage to the Stimulator's electronics.
•
Current induction through the DBS Leads and Vercise PC DBS System causing
unpredictable levels of stimulation.
•
Distortion of the diagnostic image.
•
Personal injury or death.
Note: The Lead‑Only System (before Stimulator is implanted), the Vercise Gevia System, and
the Vercise Genus System are MR Conditional. An MRI examination can be conducted
safely when all the instructions in the supplemental manual ImageReady™ MRI
Guidelines for Boston Scientific DBS Systems are followed.
For the latest version of the manual, go to www.IFU‑BSCI.com.
Patient Incapability: Patients who are unable to properly operate the Remote Control
and Charging System (when applicable) should not be implanted with the Boston Scientific
DBS System.
Poor Surgical Candidates: The Boston Scientific DBS System is not recommended for
patients who are poor surgical candidates.
Safety Information
Information for Prescribers
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