BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1953680 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23876
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 4, 2010
    Report Date
    January 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE BATTERY STATUS OF THE RETURNED DEVICE WAS CONFIRMED TO BE AT BEGINNING OF LIFE (BOL). ALL DEVICE SET SCREWS WERE EVALUATED AND ALL OPERATED NORMALLY. THE RV, RA, AND LV TIP SET SCREWS WERE REMOVED AND INSPECTED WITH NO ANOMALIES NOTED. VISUAL INSPECTION SHOWS NO ANOMALIES. THE DEVICE WAS ELECTRICALLY TESTED AND PASSED ALL TESTS. ANALYSIS HAS CONCLUDED THAT THIS DEVICE PERFORMED NORMALLY THROUGHOUT TESTING, OPERATING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT, THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND COMPETITOR RIGHT VENTRICULAR DEFIBRILLATION LEAD REVEALED THAT SEVERAL NON-SUSTAINED EPISODES WERE STORED IN THE ARRHYTHMIA LOGBOOK. THE RIGHT VENTRICULAR (RV) PACE AND SHOCK IMPEDANCE TRENDS WERE UNSTABLE. IN ADDITION, IT WAS DETERMINED THAT NOISE WHICH CAUSED OVERSENSING HAD LED TO THE DETECTION OF THE NON-SUSTAINED EPISODES. DURING THE FOLLOW UP VISIT ON (B)(6), 2010, THE LEAD MEASUREMENTS WERE NORMAL AND NO CHANGES WERE NOTED DURING PROVOCATION TESTING AND A CHEST X-RAY WAS ALSO NORMAL. THE NOISE ON THE RV AND SHOCK ELECTROGRAM'S WAS NOT ALWAYS CONSISTENT, ON OCCASION NOISE WAS ONLY PRESENT ON THE SHOCK CHANNEL. THE DECISION WAS MADE TO PERFORM A REVISION PROCEDURE TO REPLACE THE RV PACE SENSE PORTION OF THE DEFIBRILLATION LEAD. DURING THE REVISION PROCEDURE, THE LEAD WAS DISCONNECTED FROM THE DEVICE AND CHECKED THROUGH A PROGRAM SYSTEM ANALYZER WHICH REVEALED NO ABNORMAL MEASUREMENTS. THE SAME LEAD WAS RECONNECTED TO THE OLD DEVICE AND RETURNED HIGH IMPEDANCE AND HIGH THRESHOLDS. A POSSIBLE CONNECTION ISSUE WAS SUSPECTED AND DUE TO THE VARYING SHOCK IMPEDANCES MEASURED, A NEW COMPETITOR LEAD WAS IMPLANTED AND A NEW DEVICE WAS CONNECTED WITH NO FURTHER ISSUES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE EXPLANTED DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R