BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 1941162 · Received December 22, 2010

    Report

    Report Number
    3004209178-2010-10684
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 9, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT'S NEUROSTIMULATOR (INS) WAS FOUND TO BE TURNED OFF. WHEN ATTEMPTING TO TURN THE INS BACK ON A POWER ON RESET (POR) DISPLAYED ON THE PT PROGRAMMER. SHE WAS UNABLE TO REINSTATE THE STIMULATION. SHE SAW HER DOCTOR ON (B)(6) 2010 AND HER INS WAS SUCCESSFULLY TURNED BACK ON. SHE IS NOW FINE AND STIMULATION IS PROVIDING GOOD THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR LEAD: MODEL 3387S, LOT# V284893| EXPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ101187N| LEAD: MODEL 3387S, LOT# V284893| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN001447V| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN001451V| IMPLANTED: