BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2100328 · Received May 13, 2011

    Report

    Report Number
    3004209178-2011-03489
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 18, 2011
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A POR (POWER ON RESET) CONDITION. PATIENT WAS UPSET THAT HE LOST STIM SUDDENLY AND WANTED TO KNOW WHY IT HAD HAPPENED. THE PATIENT WAS NOT EXPOSED TO ANY EMI (ELECTROMAGNETIC INTERFERENCE) AND BATTERY WAS NOT NEAR END OF SERVICE. THE PATIENT WAS CONCERNED THAT THEY LOST STIMULATION SUDDENLY. ADDITIONAL INFORMATION WAS REQUESTED.

    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 60 YR IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V165754| EXTENSION: MODEL 37085, LOT# NKN001130V| PROGRAMMER: MODEL 37642, LOT# NJZ101068N| EXPLANTED:| LEAD: MODEL 3387S, LOT #V165754| EXTENSION: MODEL 37085, LOT# NKN001126V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: