Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning Neuromodulation Deep Brain Stimulation system extensions [Model number: 37085 and 37086 which can be used with Neurostimulators: Activa PC (Model 37601), Activa RC (Model 37612) and the Activa SC (Model 37603)].
The manufacturer received complaints of high impedance of extensions and has completed analysis of the 14 extensions returned between October 1st, 2014 and March 2nd, 2015. High impedance for 13 of the extensions was observed at implant and one extension after approximately two months from implant. The manufacturer's analysis of the returned extensions identified conductor wire fractures in close proximity to the location where the extension exits the connector block and not within the connector block itself.
This issue may result in prolonged surgical procedure or revision surgery depending on when the high impedance / damage is detected. If a damaged extension is not detected during the implant procedure, it could result in loss of stimulation.
The manufacturer advises users to follow the instructions defined within the Neurostimulator implant manual related to extension implantation, specifically to ensure that the extension is not bent sharply or kinked to minimize the potential for a conductor wire fracture and to check electrode impedances for open circuits, prior to pocket closure, which could indicate a potential conductor fracture.
According to the local supplier, 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 April 2015