BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK

    MDR report key: 116881 · Received August 29, 1997

    Report

    Report Number
    116881
    Event Type
    Injury
    Date Received
    August 29, 1997
    Date of Event
    August 18, 1997
    Report Date
    August 19, 1997
    Manufacturer
    CARDIAC PACEMAKERS, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    82 Y/O HX SUDDEN CARDIAC DEATH PRESENTED TO MC WITH INCREASED SHOCKS FROM ICD. HX TRANSVENOUS ICD IMPLANTED 8/16/93. ON EVAL ABNORMAL SENSING (OVERSENSING) OF THE DEVICE WAS NOTED BY BEEP-O-GRAM. PT TAKEN TO OR FOR EXTRACTION OF ENDOTAK LEAD WITH NEW SYSTEM IMPLANT. ICD WAS ALSO REPLACED DUE TO END OF LIFE STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK Implant RATE MORPHOLOGY CARDIOVERSION/DEFIBRILLATION LEAD LWS CARDIAC PACEMAKERS, INC. 0064 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization CPI 1600