Events

Safety Alert for SynchroMed Implantable Infusion Pump

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

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
    2012-11-20
  • Event Date Posted
    2012-11-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121120a.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 implantable infusion pump the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning synchromed implantable infusion pump, manufactured by medtronic limited. from the manufacturer’s investigation, use of unapproved drugs with synchromed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion. based on data from medtronic’s implantable systems performance registry, the overall failure rate of the synchromed ii pump at 78 months post implant is 2.4% when used to dispense approved drugs, and 7.0% when used to dispense unapproved drugs. the use of unapproved drugs can lead to intermittent or permanent pump motor stalls which may be reported as a loss of or change in therapy. therapy changes could potentially result in serious injury and/or death. pumps can experience motor stalls when used with either approved or unapproved drugs, however pump motor stalls have been reported at a significantly lower rate when approved drugs are exclusively used. medtronic continues to investigate motor gear corrosion, which has been identified as a primary contributor to permanent motor stall in both synchromed ii and synchromed el pumps. to minimize the potential for motor stall, the manufacturer advised user to only use the approved drugs that are identified in the synchromed infusion system labelling. do not use compounded drugs, unapproved concentrations or unapproved formulations. the manufacturer also provided the following recommendations: continue to monitor patients closely for the possible return of baseline symptoms. reinforce with patients and caregivers information on the signs and symptoms of withdrawal due to therapy cessation, and the importance of contacting their healthcare provider immediately if these signs and symptoms appear. the synchromed ii pump is designed with a critical alarm for pump motor stall. for patients implanted with a synchromed ii pump, the critical alarm interval frequency can be changed to sound every 10 minutes. retrieve logs when interrogating the synchromed ii pump in order to check for motor stall events. according to the local supplier, the affected products were distributed in hong kong. for details, please refer to mhra website http://www.Mhra.Gov.Uk/home/groups/fsn/documents/ fieldsafetynotice/con205372.Pdf if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 20 november 2012.

Device

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

Manufacturer

Medtronic Limited
  • 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