Important Safety Alerts

Medical device manufacturer, Medtronic Ltd, has issued a medical device safety alert concerning its Deep Brain Stimulation (DBS) system. The safety alert relates to two separate issues: Loss of coordination and the Tunneling Procedure of the DBS system.

Issue One - Loss of coordination

This issue relates to Activa RC (37612), Activa PC (37601), Activa SC (37602 and 37603), Activa PC+S (37604), Kinetra (7428) and Soletra (7426).

The manufacturer has become aware of a reported event of inability to swim following DBS implantation and initiation of DBS therapy for Parkinson's disease in a patient who was an experienced swimmer.

While the issue was identified in a patient being treated for Parkinson's disease (a movement disorder), it may apply to any approved DBS therapy indication.

Patients should be made aware that participating in any activities requiring coordination that they were previously able to perform may place them in an unsafe situation; therefore these activities should be performed under supervision after DBS therapy is first turned on and after programming changes until any effects of their DBS therapy on coordination are understood.

Issue Two - Tunneling Procedure

This issue relates to DBS Extensions Models 7483 and 37086, Tunneling Tools 3755, 3550-05.

The manufacturer's post marketing surveillance for DBS therapy has identified the following serious events or injuries associated with tunneling that are not presented in the current DBS labeling. The following events are associated with the DBS implant and tunneling the extension from the lead to the implantable neurostimulator (INS):

• Cases of spinal accessory nerve injury
• Severe bleeding or vascular injury
• An extension inadvertently implanted through the ribs and later found to be close to the heart requiring revision
• Tunneling too superficially resulting in an extension that exited and then re-entered the neck which was not discovered until the surgical drape was removed.

These events occurred in an estimated 0.008% of tunneling procedures.

The manufacturer advises that during the DBS implant, users should be cautious while tunneling the extension from the lead to the INS to avoid tunneling too deeply or superficially because serious injury may occur.

According to the manufacturer, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 16 May 2016