Events

Safety Alert for Deep Brain Stimulation (DBS) system pocket adaptors

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medtronic Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-06-24
  • Event Date Posted
    2016-06-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160624a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: medtronic neuromodulation deep brain stimulation (dbs) system pocket adaptors 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.

Device

Deep Brain Stimulation (DBS) system pocket adaptors
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic Neuromodulation Deep Brain Stimulation (DBS) system pocket adaptors
  • Manufacturer
    Medtronic Ltd

Manufacturer

Medtronic Ltd
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH