Events

Recall of SynchroMed II Implantable Infusion Pump

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-2014-RN-00037-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-01-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00037-1
  • 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
    The synchromed ii pump software update will automatically correct the following two issues:1) erroneous replace by date: the updated software corrects the issue previously communicated in medtronic’s march 2012 (tga ref: rc-2012-rn-00260-3) i.E., 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.2) premature reservoir alarm: the updated software corrects the potential for premature low and empty reservoir alarms. these premature alarms are due to an incorrect calculation within the 8840 programmer software. the majority of these alarms occur within the clinic immediately following an interrogation.
  • Action
    1) Medtronic does not recommend prophylactic explant of devices because these issues are addressed automatically and non-invasively with the software card update. Until the software application card is updated in the programmer: - Clinicians may continue to use the present software card. - Continue the normal follow up schedule, and monitor the estimated number of months until Elective Replacement Indicator (ERI). - Follow labelled recommendations for pump replacement within 90 days of ERI declaration. 2) In the case of a low or empty reservoir alarm: - Review the calculated residual volume displayed on the 8840 programmer to assess if the alarm is premature. - After the software update, any previous version of the model 8870 software application card should no longer be used and can be returned to Medtronic. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-synchromed-II-140204.htm .

Device

SynchroMed II Implantable Infusion Pump

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