Events

Safety Alert for SynchroMed® II 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
    2012-03-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120321a.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
    Field safety notice: medtronic synchromed® ii pump the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning the synchromed® ii pump, manufactured by medtronics inc. the notice provided important information regarding the “schedule to replace the pump by” date displayed on the model 8840 n’vision® physician programmer and printed reports, for the model 8637 synchromedr ii implantable drug infusion pump. in some circumstances after a pump’s elective replacement indicator (eri) has occurred, the “schedule to replace the pump by” date may be incorrectly displayed as a series of question marks (??/??/????), or as a date greater than 90 days from the eri date, potentially leading to the pump reaching end of service (eos) prior to replacement. medtronic has confirmed that an algorithm used in the model 8870 application card software has resulted in nine occurrences of an incorrectly displayed “schedule to replace the pump by” date. it is estimated that there are more than 140,000 synchromed ii pump implants worldwide. a patient with a pump reaching eos prior to replacement may experience the return of underlying symptoms and/or withdrawal symptoms. intrathecal baclofen patients could experience baclofen withdrawal syndrome, which can be life threatening. no adverse events have been reported for eight of the confirmed cases, and one intrathecal baclofen therapy (itb) patient experienced decreased therapeutic effect with increased spasticity due to the pump reaching eos prior to replacement. the manufacturer advised customers to take the following actions: continue normal follow up schedule, and monitor the estimated number of months until eri. follow labelled recommendations for pump replacement within 90 days* of eri declaration. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

SynchroMed® II Pump
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic SynchroMed® II 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