BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK C

    MDR report key: 608792 · Received May 7, 2004

    Report

    Report Number
    2124215-2004-06978
    Event Type
    Death
    Date Received
    May 7, 2004
    Date of Event
    December 30, 2003
    Report Date
    March 4, 2004
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION DURING THE IMPLANT (DECEMBER 19, 2003) OF THIS ICD THE INSULATION OF THE CHRONIC SHOCKING LEAD, MODEL 0072, WAS FOUND TO BE DAMAGED. THE INSULATION WAS REPAIRED AND AFTERWARD, NORMAL SHOCKING IMPEDANCES WERE REALIZED FOLLOWING DELIVERY OF LOW ENERGY SHOCKS. SEVERAL WEEKS LATER, THE ICD BEGAN TO EMIT BEEP TONES. AN INTERROGATION NOTED A SHOCKING LEAD IMPEDANCE <20 OHMS FOLLOWING THE DELIVERY OF A HIGH ENERGY SHOCK. THE PHYSICIAN ELECTED NOT TO REPLACE THE DEVICE DUE TO THE PATIENT'S POOR HEALTH AS HE WAS AWAITING A HEART TRANSPLANT. WHILE THE PATIENT WAS BEING TRANSPORTED FROM ONE HOSPITAL TO ANOTHER (JANUARY 23, 2004), HE WENT INTO VT (VENTRICULAR TACHYCARDIA) AND RECEIVED CPR AND EXTERNAL SHOCKS. HE DIED A FEW HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK C IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0072 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death