RESTORESENSOR NEUROSTIMULATORS (2016-04-28)

Starting date:

April 28, 2016

Posting date:

July 7, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-59260

• Reason
• Affected products

Affected products

A. RESTORESENSOR MULTI-PROGRAM RECHARGEABLE NEUROSTIMULATOR

B. RESTORESENSOR SURESCAN MRI NEUROSTIMULATOR

Reason

"Medtronic has confirmed several instances of recharging sessions of a restore sensor implantable neurostimulator (INS) that ended without achieving a sufficient recharge to maintain stimulation therapy. This may cause the neurostimulator to enter into a rapid battery depletion state, due to an error in the device, causing the device battery level to decrease to the over discharged state within a couple days versus the 30 day decrease to the over discharged state in normal operation.
When the neurostimulator battery is allowed to over discharge, therapy is unavailable and the patient cannot charge the neurostimulator, however, battery function may be restored using the physician recharge mode of the recharger. As noted in the current labeling, if three occurrences of over discharge occur, the neurostimulator will no longer function and must be replaced.
"

Affected products