BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2100349 · Received May 13, 2011

    Report

    Report Number
    3004209178-2011-03488
    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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. SLOWNESS AND SHAKINESS STARTED ABOUT 2-3 WEEKS AGO. THERE WAS SOME DIFFICULTY WITH FINGER DEXTERITY AS WELL. THE PATIENT HAD A HIGH POWER LINE RUNNING THROUGH HIS NEIGHBORHOOD. STIMULATION WAS ON. 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 65 YR LEAD: MODEL 3387S, LOT# V534087| LEAD: MODEL 3387S, LOT# V557335| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ107235N| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED: