Events

Safety Alert for Deep Brain Stimulation system extensions

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

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
    2015-04-16
  • Event Date Posted
    2015-04-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150416.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 system extensions 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.

Device

Deep Brain Stimulation system extensions
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic Neuromodulation Deep Brain Stimulation system extensions
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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