BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1944311 · Received December 6, 2010

    Report

    Report Number
    3007566237-2010-10246
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 29, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CONFIRMED MOTOR STALL WAS NOTED IN THE EVENT LOGS ON (B)(6) 2010 AT 1716. A TUBE SET MESSAGE WAS NOTED TWO DAYS AFTER THE STALL. THERE WAS NO MOTOR STALL RECOVERY RECORDED. THE PATIENT EXPERIENCED UNDERDOSE SYMPTOMS AND WAS IN EXCRUCIATING PAIN THE DAY THE MOTOR STALL OCCURRED. THE PATIENT WAS IN A CAR ACCIDENT PRIOR TO THE PUMP STALLING, BUT IT WAS NOT CERTAIN EXACTLY WHEN THE CAR ACCIDENT OCCURRED. POSSIBLE EMI SOURCES WERE RULED OUT. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE BUPIVICAINE AND MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N0048754| EXPLANTED:| CATHETER: MODEL 8709, LOT# N004905921| IMPLANTED:| EXPLANTED: