ACTIVA Neurostimulator Charging Systems (2016-11-01)

Starting date:

November 1, 2016

Posting date:

November 18, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-61106

• Reason
• Affected products

Affected Products

Reason

Medtronic has identified an increased number of complaints from customers involving reports of rechargers that are in an unresponsive error state, where the recharger is non-functional with a blank display screen and is beeping every 5 seconds.  When this error state occurs, the recharger is unable to recharge the neurostimulator until the recharger is reset. If the neurostimulator battery is allowed to become fully depleted, this can lead to loss of therapy and return of associated disease-specific symptoms. If the implanted neurostimulator battery is allowed to remain fully depleted, it may overdischarge, resulting in a permanent reduction in battery capacity and the need to recharge more frequently in the future.

For model 37751 Implantable Neurostimulator (INS) rechargers that are used by patients to recharge their INS devices, notification will be provided to active implanting and managing physicians of both spinal cord stimulation (SCS) and deep brain stimulation (DBS) therapies. All model 37751 rechargers that are included in model 37651, 37754 and 97754 kits may be affected by this issue.

For a subset of patients receiving DBS therapy, in rare instances, a loss of DBS therapy may result in a life threatening injury or death. For example, patients being treated for Parkinson's Disease may experience akinetic crisis, and patients treated for epilepsy may experience status epilepticus. Medtronic has not received any reports of life threatening injury or death associated with this issue.

Affected products