BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 605800 · Received February 10, 2005

    Report

    Report Number
    2124215-2005-09457
    Event Type
    Injury
    Date Received
    February 10, 2005
    Date of Event
    December 21, 2004
    Report Date
    December 22, 2004
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT ON NOVEMBER 22, 2004, AT A FOLLOW-UP CLINIC VISIT, THE BATTERY STATUS OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS MIDDLE-OF-LIFE 2 (MOL2) AND THE CHARGING TIME OF THE CAPACITOR WAS 17 SECONDS. THE PHYSICIAN SCHEDULED THE REPLACEMENT OF THE DEVICE FOR DECEMBER 22, 2004. ON THE DAY BEFORE THE SCHEDULED REPLACEDMENT, THE PATIENT EXPIRED. THE PHYSICIAN INTERROGATED THE DEVICE AFTER THE DEATH AND FOUND END-OF-LIFE HAD BEEN REACHED ON DECEMBER 20, 2004. THE DEVICE HAD PROPERLY DETECTED THE ARRHYTHMIA AND SHOCKS WERE GIVEN. FOR EACH SHOCK, THE DEVICE MEASURED A SHOCK IMPEDANCE OF LESS THAN 20 OHMS AND A SHORT CIRCUIT MESSAGE WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 0148 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention