Product Info

Vercise™ Deep Brain Stimulation Systems Information for Prescribers

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Adverse Events

The following is a list of known risks with the use of deep brain stimulation. There may be risks that

are unknown. Note that some of these symptoms may be resolved or reduced by current steering,

changing stimulation parameters, or by changing the position of the Lead during surgery.

If any of these events occur, patients should inform their healthcare provider as soon as possible.

Risks Associated With Surgical Procedure and Post‑Operative Period

• Allergic reaction to anesthesia or antibiotics including anaphylaxis

• Blood clot formation in the extremities (e.g., in the veins of the legs)

• Blood clot or air forming in or traveling through the blood stream, which can block blood

ow to parts of the lungs or other tissue that could be life‑threatening

• Brain contusion (bruising)

• Brain or cerebral spinal uid (CSF) uid infection or inammation

• CSF leaking outside the skull or collecting inside the skull abnormally

• Confusion or problems with attention, thinking, or memory (acute or chronic)

• Death

• Fibrosis (thickened skin and scarring) around the Lead Extension (including tightening,

tethering, and bowstringing)

• Hemiparesis (muscular weakness or partial paralysis on one side of the body)

• Hemiballism (uncontrollable involuntary movements of a limb or limbs on one or both

sides of the body)

• Intracranial hemorrhage (which can lead to stroke, paralysis, or death)

• Intraparenchymal cyst

• Infection

• Injury to areas next to the implant, such as blood vessels, nerves, the chest wall, and the

brain

• Injury to the nerves in the armpit (brachial plexus) leading to pain or weakness of the

arm or hand

• Neurosurgery/anesthesia risks, including unsuccessful implant and pneumonia

• Pain at the surgical site(s), headache or discomfort

• Seizures

• Speech or language difculties

• Subcutaneous hemorrhage or seroma (blood or uid collection under the skin, including

the skin over the skull)

• Stroke resulting in temporary or permanent problems

• Swelling or bruising of the muscles or skin in the area of the Lead or of the IPG implant

Possible Side‑Effects of Stimulation

• Confusion or problems with attention, thinking, or memory

• Gait difculty (trouble walking) and falls

• New onset or worsening depression, which may be temporary or permanent, and

suicidal ideations, suicide attempts, and suicide