BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1884839 · Received October 15, 2010

    Report

    Report Number
    3007566237-2010-08018
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 20, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PATIENT'S PUMP HAD UNDERGONE A MOTOR STALL, AND THE PATIENT WAS IN A LOT OF PAIN. A TWO TONE CRITICAL ALARM WAS HEARD EVERY 3 TO 4 HOURS. THE MOTOR STALL WAS CONFIRMED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. THE STALL HAD OCCURRED ON (B)(4) 2010 AT 11:48. THE PATIENT'S OUTCOME, IN ADDITION TO THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION IS BEING REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    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 39 YR IMPLANTED:| CATHETER: MODEL 8709, LOT# N004658818| EXPLANTED: