BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX

    MDR report key: 605159 · Received November 9, 2004

    Report

    Report Number
    2124215-2004-08830
    Event Type
    Death
    Date Received
    November 9, 2004
    Date of Event
    September 17, 2004
    Report Date
    September 17, 2004
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT DURING THE IMPLANT OF LEAD (4087,221525) SIX UNSUCCESSFUL ATTEMPTS WERE MADE TO FIXATE THIS LEAD INTO THE PATIENT'S RIGHT VENTRICLE. AFTER THESE ATTEMPTS, IT WAS NOTED THAT THE HELIX FAILED TO EXTEND / RETRACT. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE LEAD FROM THE PATIENT'S HEART, THE LEAD APPEARED TO BE HANGING ONTO TISSUE IN THE HEART EVEN THOUGH THE HELIX WAS IN THE RETRACTED POSITION. UPON TURNING THE THE LEAD BODY COUNTER CLOCK-WISE, THE LEAD WAS FREED. AT THIS TIME IT WAS OBSERVED THAT THE PATIENT'S BLOOD PRESSURE STARTED TO DECREASE. ATTEMPTS TO PLACE A SECOND LEAD (4087, 221801) WERE UNSUCCESSFUL, AND THE PROCEDURE WAS ABANDONED DUE TO THE WORSENING OF THE PATIENT'S CONDITION. SHORTLY AFTER THE PATIENT DIED. IT WAS PRESUMED BY THE PHYSICIAN AND MEDICAL STAFF THAT THE RIGHT VENTRICLE WAS PERFORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IS-1 BI POSITIVE FIX IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4087 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death