Events

Recall of Device Recall SynchroMed II Implantable Drug Infusion Pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Neuromodulation.

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
    67720
  • Event Risk Class
    Class 2
  • Event Number
    Z-1570-2014
  • Event Initiated Date
    2014-02-26
  • Event Date Posted
    2014-05-08
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126144
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion, implanted, programmable - Product Code LKK
  • Reason
    This recall provides important new information regarding overinfusion associated with the medtronic synchromed ii implantable pump. overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, medtronic is not re.
  • Action
    Medtronic sent a "Urgent Medical Device Correction" letter dated March 2014. The letter was sent to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter provided the Explanation of the Issue, Scope and Severity, Recommendations, and Important Guidelines. Customer visits were started by Medtronic field Representatives on February 26th, 2014. Medtronic is communicating this information to the appropriate regulatory agencies globally, including the U.S. Food and Drug Administration. We are committed to continuing to improve our product performance and services to enable you to manage your patients in a safe and effective manner. If you have questions, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am- 6pm CST.

Device

Device Recall SynchroMed II Implantable Drug Infusion Pump
  • Model / Serial
    This Medical Device Correction notification affects all SynchroMed II pumps.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - All states in USA. OUS: List not provided at this time.
  • Product Description
    Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. || The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Manufacturer Address
    Medtronic Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • 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
    USFDA