BEUDAMED
    FDA Adverse Event Death Summary report: N

    RES-Q MICRON

    MDR report key: 886214 · Received July 27, 2007

    Report

    Report Number
    2124215-2007-99674
    Event Type
    Death
    Date Received
    July 27, 2007
    Date of Event
    June 6, 2001
    Report Date
    July 19, 2007
    Manufacturer
    ITM
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT GUIDANT, THE DEVICE WAS INTERROGATED AND FOUND TO HAVE A BATTERY VOLTAGE OF 5.2V. THE DEVICE PASSED MANUAL PACEMAKER AND DEFIBRILLATOR TESTING AND THE CHARGE TIME FOR THE FIRST MANUAL CAPACITOR REFORMATION WAS WITHIN NORMAL LIMITS. THE BATTERY STATUS WAS FOUND TO BE EOS AND REMOVAL OF THE DEVICE WAS CONSISTENT WITH ADVISORY RECOMMENDATIONS.

    Description of Event or Problem · 1

    GUIDANT RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED PER THE REVISED BATTERY VOLTAGE GUIDELINES WITHIN THE MICRON ADVISORY. THE CHRONIC LEAD SYSTEM WAS NOT COMPATABLE WITH THE REPLACEMENT DEVICE AND THUS LEAD SYSTEM WAS EXTRACTED. HOWEVER, DURING THE LEAD EXTRACTION AS A RESULT OF THE LEADS BEING FIBROSED INTO THE PT'S TISSUE THE SUPERIOR VENA CAVA WAS PERFORATED RESULTING IN BLOOD LOSS AND EVENTUAL DEATH. NEW INFORMATION RECEIVED INDICATES THAT THIS PT AND/OR A REPRESENTATIVE OF THE PT HAS RETAINED LEGAL COUNSEL AND FILED A LAWSUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RES-Q MICRON IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ITM 101-09

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death