Events

Safety Alert for SynchroMed II Implantable Drug Infusion Pump

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
    2017-09-15
  • Event Date Posted
    2017-09-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170915.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 synchromed ii implantable drug infusion pump medical device manufacturer, medtronic, has issued a medical device safety alert concerning its synchromed ii implantable drug infusion pump [model numbers: 8637-20 and 8637-40]. the manufacturer has received approval to implement a design change to the synchromed ii implantable drug infusion pump that reduces the likelihood for non-recoverable motor stall, which can cause loss of therapy. for pumps manufactured prior to this design change, analysis of the post-market data estimates the pump survivability specific to non-recoverable motor stall at six years post-implant to be 97.3% for pumps exposed to on-label drugs and 91.1% for pumps exposed to off-label drugs. the most common contributing factor to motor stall is shaft wear and this is observed in 59% of synchromed ii pumps returned and analyzed for motor stall. engineering testing estimates that the new design change addresses over 99% of shaft wear and will decrease the occurrence of motor stall. the manufacturer recommends the synchromed ii infusion system be used according to approved product labeling. reliability for synchromed ii pumps used with off-label drugs will still be lower than pumps used with on-label drugs, regardless of indication. according to the manufacturer, all synchromed ii pumps are now manufactured with the new design change, although there are limited quantities of these new devices in initial production. to ensure the patients have access to uninterrupted therapy, pumps manufactured prior to this latest change will remain available. once there is sufficient inventory of the pumps with the new design, the manufacturer will no longer distribute pumps manufactured prior to this change. 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 15 september 2017.

Device

SynchroMed II Implantable Drug Infusion Pump
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic SynchroMed II Implantable Drug Infusion Pump
  • 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