Events

Recall of SYNCHROMED EL

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
    33803
  • Event Risk Class
    I
  • Event Initiated Date
    2013-06-20
  • 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
    Important safety information on synchromed ii and synchromed el infusion pumps to healthcare professionals regarding the following: 1.Pump refill procedure safety update: update to the of january 18 2011 medical device safety alert letter titled "important clinical information about pocket fills" 2.Synchromedr implantable infusion pump internal shorting: provide safety information and patient management recommendations related the potential for electrical shorting internal to the synchromed infusion pump. 3.Synchromedr implantable infusion pump priming bolus: important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the synchromedr implantable infusion pump.

Device

SYNCHROMED EL
  • Model / Serial
    Model Catalog: 8627-18 (Lot serial: All lots contact mfg); Model Catalog: 8627-10 (Lot serial: All lots contact mfg); Model Catalog: 8626L10 (Lot serial: All lots contact mfg); Model Catalog: 8626-18 (Lot serial: All lots contact mfg); Model Catalog: 8626-10 (Lot serial: All lots contact mfg); Model Catalog: 8627L10 (Lot serial: All lots contact mfg); Model Catalog: 8627L18 (Lot serial: All lots contact mfg); Model Catalog: 8626L18 (Lot serial: All lots contact mfg); Model Catalog: 8637 (Lot serial: All lots contact mfg)
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    SynchroMed EL Implantable Programmable Pump
  • 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