BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONE

    MDR report key: 1611790 · Received February 12, 2010

    Report

    Report Number
    2124215-2010-03810
    Event Type
    Death
    Date Received
    February 12, 2010
    Date of Event
    April 8, 2008
    Report Date
    February 12, 2010
    Manufacturer
    GUIDANT CORPORATION
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR ADDITIONAL INFO WAS SENT TO THE FIRST JOURNAL ARTICLE AUTHOR VIA EMAIL. TO DATE, NO RESPONSE HAS BEEN RECEIVED. BOREK PP, WILKOFF BL. PACEMAKER AND ICD LEADS: STRATEGIES FOR LONG-TERM MANAGEMENT. J INTERV CARD ELECTROPHYSIOL. 2008;23(1):59-72. NICHOLAS G. TULLO, MD: MANAGEMENT OF COMPLICATIONS ASSOCIATED WITH A FIRST-GENERATION ENDOCARDIAL DEFIBRILLATION LEAD SYSTEM FOR ICDS, AMERICAN JOURNAL OF CARDIOLOGY, AUGUST 15, 1990, 411-415.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM WAS NOTIFIED THAT A JOURNAL ARTICLE TITLED "PACEMAKER AND ICD LEADS: STRATEGIES FOR LONG-TERM MANAGEMENT" CONTAINED INFO THAT IDENTIFIED A HIGHER THAN EXPECTED LEAD FAILURE RATE FOR CPI'S ENDOTAK C ENDOCARDIAL DEFIBRILLATION LEAD WHEN USED IN CONJUNCTION WITH A CPI SUBCUTANEOUS PATCH ELECTRODE. THE LEAD FAILURE INFO SPECIFIC TO CPI PRODUCTS WAS REFERENCED FROM AN ARTICLE FROM THE AMERICAN JOURNAL OF CARDIOLOGY TITLED "MANAGEMENT OF COMPLICATIONS ASSOCIATED WITH FIRST-GENERATION ENDOCARDIAL DEFIBRILLATION LEAD SYSTEM FOR IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS". THIS STUDY REVIEWED THE COMPLICATIONS IN TEN PTS, NINE OF WHICH HAD ICDS WITH ENDOCARDIAL LEADS IN CONJUNCTION WITH EPICOSTAL PATCH ELECTRODES THAT WERE IMPLANTED IN PTS WITH SUSTAINABLE VENTRICULAR TACHYCARDIA OR VENTRICULAR FIBRILLATION. SIX LEAD SYSTEM COMPLICATIONS WERE OBSERVED DURING A FOLLOW-UP PERIOD. OF THE SIX LEAD SYSTEM FAILURES, THREE CATHETER ELECTRODE CONDUCTOR FRACTURES OCCURRED AND MANIFESTED AS OVERSENSING/DELIVERY OF INAPPROPRIATE SHOCK THERAPY (ONE PT), INABILITY TO DEFIBRILLATE DURING DFT TESTING (ONE PT) AND SUDDEN CARDIAC DEATH (ONE PT). ASYMPTOMATIC PATCH ELECTRODE CONDUCTOR FRACTURES WERE DETECTED ON ROUTINE CHEST XRAY (TWO PTS). IN ONE PT, DFT TESTING PERFORMED AT THE TIME OF IMPLANTATION RESULTED IN THE MALFUNCTION OF A CHRONIC PERMANENT PACEMAKER. HOWEVER, IT WAS UNCLEAR WHETHER THE ENDOCARDIAL SHOCK OR TRANSTHORACIC RESCUE SHOCK USED DURING DFT TESTING WAS RESPONSIBLE FOR THE DAMAGE TO THE PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE LWS GUIDANT CORPORATION TACHY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death