Events

Recall of Medtronic SynchroMed II Pumps

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia Pty 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
    RC-2017-RN-00567-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-05-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00567-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Medtronic is updating information communicated in july 2011 (rc-2011-rn-00769-3) regarding the failure rate for reduced battery performance in medtronic model 8637 synchromed ii pumps manufactured up to june 2011. updated failure rate information due to this issue:- pumps manufactured mar 2005 through dec 2010: 0.13% cumulative probability for pump failure at 72 months after implant. this rate remains within the failure rate upper bound of 0.2% reported in 2011.- pumps manufactured from jan 2011 through jun 2011: 3.17% cumulative probability for pump failure at 72 months after implant. this failure rate exceeds the upper bound estimate of 0.2% reported in 2011. a patient with a pump exhibiting reduced battery performance may experience 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.
  • Action
    Medtronic is reinforcing the advice provided in 2011. Medtronic does not recommend prophylactic replacement of SynchroMed II pumps with the prior battery design (manufactured before July 2011) because of the estimated low occurrence rates, the presence of pump alarms, and the risks associated with replacement surgery. If Low Battery Reset (critical alarm) or premature Elective Replacement Indicator (non-critical alarm) or End of Service (critical alarm) occurs, replacement surgery should be scheduled as soon as possible. Further ongoing patient management recommendations are detailed in the hazard alert communication provided to physicians. For further information, please see https://www.tga.gov.au/alert/medtronic-synchromed-ii-implantable-infusion-pump-0 .

Device

Medtronic SynchroMed II Pumps
  • Model / Serial
    Medtronic SynchroMed II PumpsModel Numbers: 8637-40 and 8637-20Manufactured before July 2011ARTG Number: 97770
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA