BEUDAMED
    FDA Recall Terminated

    Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: 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

    Recall: Z-1681-2015 · Initiated April 10, 2015

    Recall

    Recall Number
    Z-1681-2015
    Event Number
    71047
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 10, 2015
    Posted
    May 28, 2015
    Terminated
    November 23, 2015
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: 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

    Reason

    Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function.

    Action

    Customers were sent a Medtronic "Urgent Medical Device Removal" letter dated April 2015. The letter described the problem and the product involved in the recall. The letter described the "Required Actions" which included to quarantine and return the product, complete and return the Customer Confirmation Form, and to share the notification with other customers. For questions, they can contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. A second letter was sent to Healthcare Professional. The "Urgent Medical Device Correction" letter dated April 2015 described the Nature of the Device Issue, Scope and Likelihood of the Issue, Recommendations, Patient Management Recommendations and Additional Information. Advise consignees to report any malfunction or adverse event related to a device to Medtronic Neuromodulation Technical Services, at 1-800-707-0933 available weekdays from 7 am - 6pm Central Time, and to FDA'ss MedWatch Program (www.fda.gov/medwatch).

    Distribution

    Worldwide Distribution - US Nationwide including DC AND PR and in the countries of : Argentina, Austria, Belgium, France, Germany, Ireland, Italy, Japan, Luxembourg, Malta, Netherlands, Norway, Panama, Poland, Portugal, Russian Federation, San Marino, Saudi Arabia, South Korea, Spain, Switzerland, and United Kingdom.

    Quantity

    1901 (1576 US, 325 OUS)