Product Info
Safety Information
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
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Suicide: New onset or worsening depression which may be temporary or permanent is a risk
that has been reported with DBS therapy. Suicidal ideation, suicide attempts, and suicide are
events that have also been reported. Therefore, physicians should consider the following:
• Preoperatively, assess patients for the risks of depression and suicide. This assessment
should consider both the risk of depression and suicide as well as the potential clinical
benets of DBS therapy for the condition being treated.
• Postoperatively, actively monitor patients for new or worsening symptoms of depression,
suicidal thoughts or behaviors, or changes in mood or impulse control.
• If a patient experiences new or worsening depression or suicidal ideation, manage these
symptoms appropriately.
• Educate patients and caregivers about these potential risks prior to implantation, and be
sure that they know about the importance of ongoing support and follow‑up, including
when to contact their health care provider.
Therapeutic Ultrasound: Implanted components of the Boston Scientic DBS System
should not be exposed to therapeutic levels of ultrasound energy. The implanted device may
concentrate the ultrasound eld and may cause patient harm.
Unauthorized Modication: Unauthorized modication to the medical devices is prohibited.
The integrity of the DBS System could be compromised and harm or injury to the patient could
occur.