BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1033623 · Received April 24, 2008

    Report

    Report Number
    2182207-2008-02203
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 15, 2008
    Report Date
    March 24, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL OCCURRED; THE EVENT LOGS SHOWED THAT APPROXIMATELY 3 MONTHS PRIOR A MOTOR STALL HAD OCCURRED WITH RECOVERY 6 HOURS AND 10 MINUTES LATER. A SECOND MOTOR STALL OCCURRED WITH RECOVERY APPROXIMATELY 1.5 HOURS LATER TWO MONTHS AFTER THE INITIAL STALL. NINE DAYS PRIOR TO THE REPORT, THE PUMP MOTOR STALLED AND "STOPPED PUMP PERIOD MAY EXCEED TUBE SET" WAS NOTED IN THE LOGS ON THE DAY OF THE REPORT. THE PT EXPERIENCED WITHDRAWAL SYMPTOMS INCLUDING THE FOLLOWING: HEADACHE, INCREASED PAIN, NAUSEA, VOMITING, PILOERECTION, DIAPHORESES AND ANXIETY. THE PUMP CONTAINED MORPHINE 50 MG/ML WITH A DAILY RATE OF 10MG. A ROTOR STUDY WAS COMPLETED IN 2008, AND SHOWED A STALLED ROTOR. THE HCP REPORTED THAT THE DEVICE WAS REPLACED AND THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL 8840 LOT# UNK| CATHETER MODEL 8731 LOT# N002575410 IMPLANTED| EXPLANTED