BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1081967 · Received July 23, 2008

    Report

    Report Number
    3004209178-2008-04277
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATION TURNS ON AND/OR OFF. IT WAS RECOMMENDED TO X-RAY THE LEAD AND EXTENSION. IT WAS ALSO RECOMMENDED TO MEASURE IMPEDANCES WHEN THE PT FEELS STIMULATION (GOOD TREMOR CONTROL) AND WHEN THE PT ASSUMES A POSITION WHERE HE LOOSES THE EFFECTIVENESS OF TREMOR CONTROL TO CONFIRM INTERMITTENCY. ADD'L INFO WAS REQUESTED FROM THE HEALTH CARE PROFESSIONAL, HOWEVER, THE HEALTH CARE PROFESSIONAL STATED HE WAS UNAWARE OF THE EVENT. REFER TO MANUFACTURER REPORT #6000032-2008-04279.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR EXTENSION MODEL 7482 LOT#NGK018755N| IMPLANTED| LEAD MODEL 3387 LOT#J0225545V| EXPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| EXTENSION MODEL 7482 LOT#NGK018505N| IMPLANTED| EXPLANTED| IMPLANTED| LEAD MODEL 3387 LOT#J0222877V| LOT#NFW112183H| EXPLANTED| IMPLANTABLE NEUROSTIMULATOR MODEL 7426| EXPLANTED