BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2160912 · Received June 16, 2011

    Report

    Report Number
    3007566237-2011-04518
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 20, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    WHEN THE PATIENT WAS SITTING THE PUMP, THE PUMP WAS PERPENDICULAR TO THE ABDOMINAL WALL. WHEN THE PATIENT WAS SUPINE, THE PUMP WAS PARALLEL. THE PUMP CONTINUED TO FLIP BACK AND FORTH. A PUMP REVISION WAS BEING CONSIDERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR CATHETER: MODEL 8598A, LOT# N235016003| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8596SC, LOT# N254567007| IMPLANTED:| EXPLANTED: