BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIENT

    MDR report key: 2052791 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04012
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 25, 2011
    Report Date
    April 4, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE ALERT WAS ISSUED FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED WITH ANOTHER MANUFACTURER'S DEFIBRILLATION LEAD, DUE TO SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. NOISE WAS ALSO OBSERVED ON THE RATE/SENSE CHANNEL WHICH WAS OVERSENSED AND RESULTED IN NONSUSTAINED VENTRICULAR TACHYCARDIA EPISODES. NO THERAPY WAS DELIVERED AS A RESULT OF THE NOISE. AN INVASIVE PROCEDURE WAS PERFORMED TO REPLACED THE LEAD. HIGH SHOCK IMPEDANCE MEASUREMENTS CONTINUED TO BE OBSERVED WITH THIS DEVICE AND THE NEWLY IMPLANTED LEAD. NUMEROUS TROUBLESHOOTING TECHNIQUES WERE ATTEMPTED WITH MEASUREMENTS REMAINING HIGH. THE DEVICE WAS THEN EXPLANTED AND SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E030

    Patients

    Seq Age Sex Outcome Treatment
    1 163 MO Required Intervention 4076| T180| E030| 6931| T175