BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2021799 · Received February 25, 2011

    Report

    Report Number
    3004209178-2011-01469
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    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

    RECEIVED INFORMATION AFTER THE INS WAS REPLACED LOW OUT OF RANGE IMPEDANCES WERE NOTED. RIGHT SIDED IMPEDANCES WERE:C8:140, C9:659, C10:952, C11:659, 8/9; 1199, 8/10: 1524, 8/11: 1199, 9/10: 936, 9/11:32 AND 10/11:936. MEDTRONIC TECHNICAL SERVICES RECOMMENDED X-RAYS OF THE LEAD AND EXTENSION AREAS. POSSIBLY REPROGRAMMING TO ADDRESS STIMULATION NEEDS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    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 74 YR EXTENSION: MODEL 37085, LOT# NKN014054V| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ109665N| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0421488V| EXTENSION: MODEL 37085, LOT# NKN014052V| LEAD: MODEL 3387, LOT# J0421488V