Events

Recall of ACTIVA PC INS - MULTI-PROGRAM NEUROSTIMULATOR

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
    27191
  • Event Risk Class
    II
  • Event Initiated Date
    2015-07-22
  • 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
    The purpose of this notification is to notify implanting and follow up physician of information that is being added to the warnings and adverse events sections of medtronic's deep brain stimulation (dbs) labeling. these labeling updates result from medtronic's ongoing monitoring of reported events clinical trials and published literature. the labeling updates further clarify potential risks which have been reported with dbs therapy. medtronic is sharing this information with physicians to help with management of current patients treated with dbs therapy. additional warnings being added to the labeling: dbs therapy for dystonia: status dystonicus - severe life-threatening dystonia symptoms including status dystonicus (also known as dystonic crisis or dystonic storm) during ongoing or loss of dbs therapy may result in respiratory compromise and rhabdomyolysis. in rare cases rhabdomyolysis may progress to multi-organ failure and death. monitor patients receiving dbs therapy for these symptoms. emphasize the importance of contacting the patient's physician if they experience increased severity of symptoms. dbs therapy for epilepsy: return of symptoms - cessation or reduction of stimulation may potentially lead to an increase in seizure frequency or severity. symptoms may return with intensity greater than was experienced prior to system implant including the potential for status epilepticus. emphasize the importance of contacting the patient's physician if they experience worsening of seizure frequency or severity. it is also important that the patient or caregiver knows how to use the patient programmer in case the neurostimulator is accidentally turned off. additional adverse events being added to the labeling for all indications of dbs therapy: meningitis encephalitis or brain abscess resulting from infection involving the brain and/or central nervous system focal edema localized to the area around the lead immediate or delayed intracranial hemorrhage or cerebral infarction which could be symptomatic or which could result in temporary or permanent neurological injury or death aseptic intraparenchymal cyst formation around the distal lead tip.

Device

ACTIVA PC INS - MULTI-PROGRAM NEUROSTIMULATOR
  • Model / Serial
    Model Catalog: 37601 (Lot serial: All lots); Model Catalog: 7426 (Lot serial: All Lots); Model Catalog: 37603 (Lot serial: All Lots); Model Catalog: 37602 (Lot serial: All Lots); Model Catalog: 7428 (Lot serial: All Lots); Model Catalog: 37612 (Lot serial: All Lots)
  • Product Description
    ACTIVA PC INS - MULTI-PROGRAM NEUROSTIMULATOR
  • 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