Events

Field Safety Notices about SynchroMed II Programmable Implantable Infusion Pump

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Medtronic Inc.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Date Posted
    2013-01-08
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2013/08/01/vazno-obavestenje-o-medicinskom-sredstvu-synchromed-ii-programmable-implantable-infusion-pump-model8637/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    Within the synchromed pump, feedthroughs are components that provide an electrically insulated path for current to flow from the electroniccircuitry to the motor. an electrical short can occur when ions from the drug solution and humidity permeate through the drug pathway tubing inside the pump and interact with the feedthrough over time. an electrical short circuit in a feedthrough may present as a motorstall or low battery reset/alarm and leadto a loss of or reduction in therapy which may result in the return of underlying symptoms and/or withdrawal symptoms. synchromed pump internal feedthrough shorts can lead to a loss of or reduction in therapy which may result in a return of underlying symptoms and/or withdrawal symptoms.Patients receiving intrathecal baclofen therapy are at risk for baclofen withdrawal syndrome, which can lead to a life threatening condition if not promptly and effectively treated.Surgical revision to replace or remove the pumps may be required for patients with pumps experiencing repeated motor stalls, low battery resets (with or without safe state), or a premature elective replacement indicator.

Device

SynchroMed II Programmable Implantable Infusion Pump

Manufacturer

Medtronic Inc
  • 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
    ALIMSA