BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3200095 · Received July 1, 2013

    Report

    Report Number
    3007566237-2013-00994
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    December 5, 2007
    Report Date
    December 5, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP ALARMED DUE TO MOTOR STALL. THE LOGS SHOWED A MOTOR STALL AND MOTOR STALL RECOVERY. THE MOTOR STALL WAS CAUSED BY THE HEALTHCARE PROVIDER (HCP) USING A MAGNET WHILE TRYING TO PREFORM TELEMETRY ON THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297781 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR