BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2043202 · Received March 25, 2011

    Report

    Report Number
    3007566237-2011-02305
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Report Date
    March 10, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0591-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CONFIRMED MOTOR STALL WITH NO RECOVERY WAS REPORTED AFTER THE PT HAD AN MRI. THE PUMP STILL HAD NOT RECOVERED 2 HRS AFTER THE MOTOR STALL WAS INITIALLY LOGGED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO 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 CATHETER: MODEL 8709SC, LOT# N172894007| IMPLANTED:| EXPLANTED: