BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA SC

    MDR report key: 2093001 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-03260
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 18, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTED LEAD WAS CONNECTED TO THE BROWN SCREENER BOX; THEY TRIED TO TURN STIMULATION UP TO 10 V AND GOT NOTHING. THE LEAD WAS REPLACED WITH A NEW LEAD AND AT 3 V THE PATIENT STARTED RECEIVING SOME STIMULATION. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA SC MHY MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU223791V| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU225190V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V568830| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ111269N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V526050| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V530287| IMPLANTABLE NEURO STIMULATOR: MODEL 37602| LOT# NLA700425H