BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2181405 · Received July 21, 2011

    Report

    Report Number
    9614453-2011-05643
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN PROGRAMMER DISPLAYED AN OUT OF REGULATION (OOR) MESSAGE. IMPEDANCES WERE MEASURED AND ELECTRODES 10 AND 11 WERE >40,000 OHMS. THE PATIENT WAS NOT SATISFIED WITH THE OUTCOME USING THE OTHER ELECTRODES, SO THE CONNECTION AND LEAD IMPEDANCES WERE TESTED INTRAOPERATIVELY. THE LEAD AND EXTENSION CONNECTION WAS OPENED, AND IMPEDANCES WERE "OK" WHEN TESTING IMPEDANCES WITH THE TWIST LOCK CABLE AND EXTERNAL NEUROSTIMULATOR. THE LEAD AND EXTENSION WERE RECONNECTED AND THE LEAD IMPEDANCES WERE TESTED AT THE STIMULATOR WITH A STERILE BAG. THE IMPEDANCES WERE STILL HIGH. NEXT, THE STIMULATOR WAS "OPENED" IN ORDER TO TEST THE EXTENSION. THE EXTENSION HOWEVER WAS CUT THROUGH WHILE PREPARING IT, SO NO IMPEDANCES WERE TESTED. A NEW EXTENSION WAS IMPLANTED, AND AFTERWARDS THE IMPEDANCES WERE "OK." IMPEDANCES WERE MEASURED AFTER THE PATIENT WAS CLOSED UP AND EVERYTHING WAS STILL OK. THE PHYSICIAN DID NOT EXPECT ANY FURTHER ACTION NEEDED TO BE TAKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MEDTRONIC EUROPE SARL 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention