The implantable devices deliver electrical stimulation to the patient’s brain for the treatment of movement disorders, epilepsy, Parkinson’s disease, and other neurological conditions.
The Australian Therapeutic Goods Administration (TGA) issued a Hazard Alert for Medtronic neurostimulation devices for deep brain stimulation, including:
- Activa PC – 37601
- Activa SC – 37603
- Activa RC – 37612
- Kinetra – 7428
- Soletra – 7426
Unfortunately, when neurostimulators are used for dystonia (muscle disorder), it can lead to life-threatening complications such as:
“…status dystonicus (also known as dystonic crisis or dystonic storm), during ongoing or loss of deep brain stimulation therapy may result in respiratory compromise and rhabdomyolysis. In rare cases, rhabdomyolysis may progress to multi-organ failure and death.”
When neurostimulators are used for epilepsy patients, the agency warns that stopping or reducing stimulation may increase the frequency or severity of seizures.
New risks updated for all uses of deep brain stimulation therapy:
- Meningitis, encephalitis, or brain abscess resulting from infection involving the brain or central nervous system
- Focal oedema localized around the lead wire
- Immediate or delayed intracranial hemorrhage
- Stroke (cerebral infarction)
- Cyst formation around the tip of the lead wire
In February 2015, the Justice Department announced a $2.8 million settlement to resolve allegations that Medtronic illegally marketed the “SubQ” neurostimulation device for unapproved treatment of chronic pain from 2007-2011. Click here to read more.
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