BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2942122 · Received February 4, 2013

    Report

    Report Number
    3007566237-2013-00361
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    January 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CATHETER MODEL 8709, LOT# L64346, IMPLANTED: (B)(6) 1999. (B)(4). ONLY THE PUMP WAS RETURNED. FINAL ANALYSIS OF THE PUMP REVEALED MOTOR/GEAR TRAIN ANOMALY AND/OR WEAR AND/OR LUBRICATION ISSUE. BACLOFEN WAS FOUND IN THE RESERVOIR.

    Description of Event or Problem · 1

    PUMP WAS REMOVED PROPHYLACTICALLY TO AVOID IN-VIVO BATTERY DEPLETION. PATIENT RECOVERED WITHOUT SEQUELLA. RETURNED FOR DISPOSAL. DEVICE SYSTEM WAS USED TO INFUSE DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46621 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR