Events

Recall of ACTIVA RC NEUROSTIMULATOR - DBS EXTENSION KIT FOR DEEP BRAIN STIMULATION

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDTRONIC OF CANADA LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    111327
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-17
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Notification regarding information that will be added in the future to medtronic's deep brain stimulation (dbs) labeling. the labeling updates further clarify potential risks which have been reported with dbs therapy. medtronic is sharing this information to help with management of current and future patients treated with dbs therapy. medical safety assessment evaluated reports of a loss of swimming ability or drowning following dbs implant. the dbs manuals reviewed as part of the msa identified language describing the potential for loss of coordination however this language does not describe the potential for changes in swimming ability due to dbs therapy and the associated risk of drowning in the dbs patient population. medical safety assessment (msa) evaluated reports of serious injury associated with tunneling for dbs therapy. the dbs manuals reviewed as part of the msa do not describe some of the risks associated with tunneling identified in the msa which include spinal accessory nerve injury vascular injury tunneling too deeply too superficially or tunneling through unintended anatomy (such as in between the ribs or entering the thoracic cavity). note: the tunneling tool model associated with these injuries was not reported for some of these events.

Device

ACTIVA RC NEUROSTIMULATOR - DBS EXTENSION KIT FOR DEEP BRAIN STIMULATION
  • Model / Serial
    Model Catalog: 37086 (Lot serial: All Lots); Model Catalog: 7428 (Lot serial: All Lots); Model Catalog: 37603 (Lot serial: All Lots); Model Catalog: 37602 (Lot serial: All Lots); Model Catalog: 37612 (Lot serial: All Lots); Model Catalog: 37601 (Lot serial: All Lots); Model Catalog: 7426 (Lot serial: All Lots); Model Catalog: 7483 (Lot serial: All Lots)
  • Product Description
    ACTIVA RC NEUROSTIMULATOR - DBS EXTENSION KIT FOR DEEP BRAIN STIMULATION;KINETRA NEUROSTIMULATOR PULSE GENERATOR & ACCESSORY KIT;ACTIVA SC - NEUROSTIMULATOR;ACTIVA PC INS - DBS EXTENSION KIT FOR DEEP BRAIN STIMULATION;ACTIVA RC MULTI-PROGRAM RECHARGEABLE
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Manufacturer Address
    BRAMPTON
  • 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
    HC