The Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom posted a medical device safety alert concerning Metalline wound, drainage, tracheo dressings manufactured by Lohmann & Rauscher GmbH & Co.KG.
Medical device manufacturer, Medtronic Ltd, has issued a medical device safety alert concerning its Neuromodulation Deep Brain Stimulation (DBS) system pocket adaptors (Models 64001 and 64002) which can be used with the implantable Neurostimulators: Activa PC (Model 37601) and Activa RC (Model 37612).
The manufacturer has identified sixteen DBS pocket adaptors that were returned for high impedance measurements and where subsequent manufacturer's analysis identified conductor wire fractures in close proximity to the location where the adaptor wire exits the neurostimulator connector block. Of the sixteen returned devices, two were returned after the issue was identified intraoperatively, and 14 were returned after the issue was identified post-implant (requiring revision surgery).
According to the manufacturer, approximately 20,000 DBS pocket adaptors have been sold worldwide since product launch in 2009, for a 0.08% reported rate of occurrence.
The design of the pocket adaptor conductor body is similar to that of DBS Extensions, Models 37085 and 37086. The manufacturer issued a Medical Device Safety Notification for these extension models in April 2015, reinforcing device labeling specific to the handling of extensions and system integrity checking during implant procedures due to the fracture rate seen in extensions at that time.
Current labeling for the handling of the system during implant is described within the implant manuals. The manufacturer advises users to follow the instructions defined within the DBS Pocket Adaptor Implant Manual, specifically to ensure that the adaptor wire is not bent sharply or kinked at the time of implant.to minimize the potential for a conductor wire fracture
In addition, users are advised to complete a system integrity check for proper electrode impedances prior to pocket closure, as described in the Activa PC Model 37601 Implant manual.
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 24 June 2016