BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2093934 · Received May 16, 2011

    Report

    Report Number
    6000030-2011-03572
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    July 22, 2010
    Report Date
    April 19, 2011
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B(4). FINAL DEVICE ANALYSIS REVEALED MOTOR GEAR CORROSION. CORROSION AND RESIDUE WAS SEEN ON THE LOWER SHAFT OF GEAR 3, 4 AND 6 (ROTOR MAGNET). A MOTOR STALL WAS CONFIRMED VIA X-RAY.

    Description of Event or Problem · 1

    THE PUMP WAS REPLACED DUE TO BATTERY DEPLETION. THE MEDICATIONS IN THE PUMP WERE FENTANYL AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11381R18