BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1011289 · Received March 11, 2008

    Report

    Report Number
    3004209178-2008-01196
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    December 12, 2007
    Report Date
    February 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS, WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2007 THE PATIENT RETURNED FROM A TRIP, AND IN THE AIRPORT PASSED THROUGH SEVERAL SECURITY CONTROLS INCLUDING METAL DETECTORS. ON THE DAYS FOLLOWING, SHE HAD WORSENING OF HER PAIN. AT HER FOLLOW UP VISIT, THE HCP NOTICED THAT THE REFILL DATE HAD SHIFTED OUT ABOUT 1 MONTH, SO HE SUSPECTED THAT THIS MEANT THE PUMP HAS BEEN STOPPED FOR SOME TIME. THE HCP REFILLED THE PUMP AND REPROGRAMMED IT. THE PATIENT CONTINUED TO HAVE PAIN. THE HCP DECIDED TO REPLACE THE PUMP. THE PATIENT WAS DOING WELL SINCE THE PUMP REPLACEMENT. THE PUMP WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention