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TGA Warning for Medtronic Deep Brain Stimulation Devices

July 23, 2015 — New warning about life-threatening side effects have been added to the label on several Medtronic neurostimulation implants by the Australian Therapeutic Goods Administration (TGA).

Neurostimulation devices are programmable, implanted devices that deliver electrical signals to the brain. They are used to treat epilepsy, Parkinson’s disease, movement disorders, and other neurological syndromes.

The problem is that they have also been linked to serious complications. The TGA has issued a Hazard Alert for the following neurostimulation devices made by Medtronic:

  • Activa PC – 37601
  • Activa SC – 37603
  • Activa RC – 37612
  • Kinetra – 7428
  • Soletra – 7426

According to the TGA, deadly side effects can occur when the devices are used to treat a muscle disorder known as dystonia, 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.”

In epilepsy patients, neurostimulation devices can also increase the frequency or severity of seizures when stimulation is reduced or stopped.

Other side effects linked to 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

This is not the first time Medtronic has come under fire for its neurostimulation devices. In February, Medtronic paid a $2.8 million settlement after they were accused of marketing the “SubQ” neurostimulation device for the “off-label” (unapproved) treatment of chronic pain.

Earlier this year, Medtronic also agreed to pay a $4.4 million settlement to resolve allegations that it deliberately violated U.S. law by selling medical devices to the military that were made in China or Malaysia and relabeling them “Manufactured in Memphis, TN.”

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