BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3200028 · Received July 1, 2013

    Report

    Report Number
    3007566237-2013-01045
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    September 2, 2005
    Report Date
    September 2, 2005
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A MOTOR STALL OCCURRED AT 08:11 AND RECOVERED AT 08:17. AN ATTEMPT TO READ THE PUMP WITH A MAGNET WAS MADE. THE OUTCOME WAS LISTED AS ¿NORMAL FUNCTION, NO ACTION NEEDED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299915 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1