BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2181597 · Received July 5, 2011

    Report

    Report Number
    3007566237-2011-05065
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 12, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CONFIRMED MOTOR STALL WITH NO RECOVERY WAS REPORTED. THE PUMP HAD ALARMED 24 HOURS PRIOR AND SHOWED ONE STALL IN EVENT LOGS. THE PUMP WAS 6 YEARS OLD AND WAS GOING TO BE REPLACED. NO INFORMATION WAS AVAILABLE ON PATIENT AND DRUG STATUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK