Suicide
New onset or worsening depression which may be temporary or permanent is a risk that has been reported with DBS therapy.
Suicidal thoughts, suicide attempts, and suicide are events that have also been reported. Patients and caregivers should
consider the following:
•
Be sure you talk to your treating healthcare provider(s) if you have a history of depression, suicidal thoughts, or have
attempted suicide. Be sure you understand the possible risks of new onset or worsening depression (including suicidal
thoughts) as well as the potential clinical benefits of DBS therapy.
•
After the procedure, if you notice unusual changes in mood or behavior (such as increased anxiety, sleeping problems,
loss of interest in activities, feeling of hopelessness, mood swings, weight loss or weight gain), or impulse control,
contact your healthcare provider. If you are having thoughts of suicide, contact your healthcare provider or emergency
services immediately.
•
It is important to attend on going follow-up visits with your healthcare provider to manage your therapy.
Therapeutic Ultrasound
Do not expose the implanted components of the DBS System to therapeutic ultrasound.
Unauthorized Modification
Unauthorized changes to the medical devices are not allowed. If unauthorized changes are made to the devices, the integrity of
the devices could be at risk and you may be harmed or injured.
Safety Information
Information for Patients
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