BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 1926039 · Received November 10, 2010

    Report

    Report Number
    3004209178-2010-09229
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 22, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A POWER-ON RESET (POR) MESSAGE ON THE PT PROGRAMMER SCREEN. THERE WAS A LOSS OF THERAPEUTIC EFFECT, AND THE STIMULATION COULD NOT BE ADJUSTED. THE POR MESSAGE HAD BEEN SHOWING FOR "SEVERAL DAYS." THE PT HAD BEEN GOING THROUGH RADIATION THERAPY FOR THE PAST 6.5 WEEKS. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR EXPLANTED:| EXTENSION: MODEL 37085, LOT #: NKN010027V| LEAD: MODEL 3387, LOT #: V353787| EXPLANTED:| EXTENSION: MODEL 37085, LOT #: NKN010026V| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37642, LOT #: NJZ102375N| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT #: V281277| EXPLANTED:| IMPLANTED: