BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2023080 · Received February 24, 2011

    Report

    Report Number
    3007566237-2011-01421
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 9, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CONFIRMED PUMP MOTOR STALL WITH NO MOTOR STALL RECOVERY WAS NOTED IN THE EVENT LOGS. ACCORDING TO THE PUMP LOGS, THERE WERE VARIOUS MOTOR STALLS AND RECOVERIES OVER A PERIOD OF A FEW MONTHS. THE PT DID NOT EXPERIENCE ANY WITHDRAWAL SIDE EFFECTS. THE PT'S MOTHER HEARD THE PUMP ALARM AND BROUGHT THE PT IN FOR EVAL. ALL ENVIRONMENTAL EMI SOURCES WERE ELIMINATED AS A POSSIBLE CAUSE FOR THE STALL. THE PT WAS PRESCRIBED ORAL BACLOFEN. A F/U APPOINTMENT WAS SCHEDULED. THE PT STATUS WAS "FINE". THE PUMP WAS USED TO DELIVER COMPOUNDED BACLOFEN. 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 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR CATHETER: MODEL 8709, LOT# J12526R30| EXPLANTED:| IMPLANTED: