Medtronic DBS Mode D'emploi page 21

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Complications related to anesthesia, including allergic reaction, hypotension, nausea
and vomiting, headache, and other symptoms
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Complications or effects related to the device implantation or removal procedure,
including lead insertion or removal difficulty, failure of the burr hole ring and cap,
mechanical or electrical complications of the device, lead(s) not within target
requiring replacement
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Complications or effects related to the tunneling procedure, including injury to nerve
tissue (such as the spinal accessory nerve), vascular injury that may result in
prolonged hospitalization, and tunneling through unintended anatomy (such as in
between the ribs and entering the thoracic cavity)
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Cerebrospinal fluid leakage (also called CSF fistula)
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Pneumocephalus
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New onset seizures associated with the lead implant procedure
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General medical complications such as deep vein thrombosis, postoperative fever,
and general postoperative discomfort
Risks (potential adverse events) after implantation of the lead(s), extension(s), or
neurostimulator(s):
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Delayed intracranial hemorrhage or cerebral infarction which could be symptomatic,
or which could result in temporary or permanent neurological injury or death
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Complications of the incision/surgical site, including inflammation, lack of healing,
wound dehiscence, transient or persistent pain, seroma, or hematoma
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Infection of the incision/surgical site that could result in sepsis
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Meningitis, encephalitis, or brain abscess resulting from infection involving the brain
and/or central nervous system
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Focal edema localized to the area around the lead
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Aseptic intraparenchymal cyst formation around the distal lead tip that may occur
weeks to months after implant and may present as new neurological symptoms.
Surgical removal of the lead may reduce the size of the cyst and the neurological
symptoms caused by cyst formation.
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Erosion of the skin at the lead, extension, or neurostimulator site
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Migration or dislodgement of the lead, extension, or neurostimulator
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Lead, extension, or neurostimulator device complications, including lead or extension
fracture, neurostimulator malfunction, neurostimulator setscrews not adequately
tightened, and high impedance
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Fibrosis (including tightening, tethering, or bowstringing) at the extension or
neurostimulator site may develop weeks to years after implant. It can be associated
with pain, disfigurement, limited head mobility, and may require surgical intervention.
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Neurological symptoms, new or exacerbation of existing symptoms which might be
transient or permanent, including:
– vision disorders: diplopia, oculomotor difficulties, or other visual field disorders.
– speech and swallowing disorders: dysphagia, dysarthria, dysphasia, drooling.
Information for prescribers 2017-05-01 English 17