Events

Recall of SynchroMed II and SynchroMed EL Implanted 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-2013-RN-00678-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00678-1
  • 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 clinician refill reference card for synchromed implantable infusion systems that was originally distributed with the january 2011 safety alert (tga ref.: rc-2010-rn-01266-3) related to pocket fills has been updated to align with new product labelling. the january 2011 medical device correction letter provided important reminders concerning the potential for a pocket fill during a synchromed ii or synchromed el implantable drug pump refill procedure, and important patient management recommendations. a pocket fill is the inadvertent injection of all or some of the prescribed drug into the patient’s subcutaneous tissue, which includes the pump pocket, instead of the pump which can lead to life-threatening symptoms, serious patient injury, or death due to overdose or underdose.
  • Action
    The main title of the Clinician Refill Reference Card has been updated to read Critical Actions in the Pump Refill Procedure, and the updates to the card include: - A description of the card’s purpose regarding pocket fill - A reminder to clinicians of the critical steps for ensuring the pump is correctly refilled - Detail regarding proper alignment of the refill template - Information for actions to take if a pocket fill is suspected - Removal of the note related to glucose testing Medtronic has updated product manuals and is in the process of deploying the updated labelling. Current labelling for product manuals can be found at www.medtronic.com/manuals. For more details, please see http://www.tga.gov.au/safety/alerts-device-synchromed-130718.htm .

Device

SynchroMed II and SynchroMed EL Implanted 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