BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2732927 · Received September 7, 2012

    Report

    Report Number
    3004209178-2012-07867
    Event Type
    Injury
    Date Received
    September 7, 2012
    Report Date
    August 8, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 7085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V851361, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROGRAMMING SESSION WITH PHYSICIAN, HIGH IMPEDANCES (>40,000 OHMS) WERE OBSERVED ON THE IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE LEFT HEMISPHERE OF THE PATIENT. X-RAYS WERE TAKEN BUT WERE INCONCLUSIVE. THE PATIENT THEN WAS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2012. AT THE BEGINNING OF THE PROCEDURE IMPEDANCES MEASURED >40,000 OHMS. THE POCKET WAS THEN OPENED, THE EXTENSION WAS DISCONNECTED FROM THE INS, CONNECTIONS BLOTTED DRY, AND RECONNECTED BUT HIGH IMPEDANCES WERE STILL OBSERVED. THE CONNECTION BETWEEN THE EXTENSION AND THE LEAD WAS THEN DISCONNECTED, DRIED AND RECONNECTED WITH THE SAME HIGH IMPEDANCE RESULTS. A NEW EXTENSION WAS THEN CONNECTED TO THE LEAD, RUN EXTERNALLY OVER THE CHEST AND CONNECTED TO THE INS (IN THE POCKET) WITH THE RESULTS THAT NORMAL IMPEDANCES WERE MEASURED. THE OLD EXTENSION WAS THEN REPLACED AND THE NEW EXTENSION TUNNELED AND CONNECTED TO THE EXISTING INS. ALL IMPEDANCES WERE MEASURED AS NORMAL AND THE INCISIONS WERE CLOSED UP. THOUGH CUT BY THE PHYSICIAN TO REMOVE, OBSERVATIONS OF THE EXPLANTED EXTENSION SHOWED NO OBVIOUS BREAKS OR ANY PROTRUDING WIRES. THE PATIENT WAS REPORTED AS DOING FINE AND THE PHYSICIAN WAS CONTINUING TO REPROGRAM AS NECESSARY FOR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention