BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 1952038 · Received January 4, 2011

    Report

    Report Number
    3004209178-2011-00006
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 16, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    HIGH, OUT-OF-RANGE IMPEDANCES WERE FOUND ON 3 OF THE 4 DEEP BRAIN STIMULATOR ELECTRODES. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 13 YR PROGRAMMER: MODEL 37642, LOT# NJZ101012N| EXPLANTED:| LEAD: MODEL 3387, LOT# V256559| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN000637V| IMPLANTED:| LEAD: MODEL 3387, LOT# V256559| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN003696V