BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1852907 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-17064
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    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

    A DEVICE MEMORY DISK WAS OBTAINED FOR FURTHER ANALYSIS. BASED UPON DIAGNOSTIC INFORMATION WITHIN THE DEVICE MEMORY DATA, BOSTON SCIENTIFIC ENGINEERS CONCLUDED THAT THE DEVICE BATTERY MAY BE DEPLETING PREMATURELY. THE LOCAL FIELD REPRESENTATIVE WAS NOTIFIED OF THE DISK ANALYSIS RESULTS, AND A RECOMMENDATION WAS MADE TO EXPLANT THE DEVICE AND RETURN IT FOR ANALYSIS. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS. THE DEVICE CASE WAS REMOVED AND INTERNAL VISUAL INSPECTION NOTED NO IRREGULARITIES. AN EXTERNAL POWER SOURCE WAS CONNECTED TO THE DEVICE AND INTERNAL MEASUREMENTS NOTED A HIGH CURRENT DRAIN. FURTHER DETAILED TESTING ISOLATED THE PROBLEM TO A DEGRADED TANTALUM CAPACITOR THAT PREMATURELY DEPLETED THE BATTERY. THIS ISSUE IS DISCUSSED IN THE Q3 2010 PRODUCT PERFORMANCE REPORT. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REPORTEDLY EXHIBITING AN 8.5 YEAR REMAINING LONGEVITY ESTIMATE AFTER APPROXIMATELY 13 MONTHS OF IMPLANT. APPROXIMATELY THREE MONTHS LATER WHEN THE PATIENT WAS CHECKED IN CLINIC BY A HEALTHCARE PROFESSIONAL (HCP), THE DEVICE'S ESTIMATED REMAINING LONGEVITY WAS REPORTEDLY 3 YEARS. THERE WERE NO KNOWN PROGRAMMING CHANGES DURING THIS TIME, AND THE PATIENT HAD NOT RECEIVED A SIGNIFICANT AMOUNT OF SHOCK THERAPY. THE HCP QUESTIONED WHY THIS DROP IN ESTIMATED REMAINING LONGEVITY MAY HAVE OCCURRED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention 0148| A135| 4137| E110| 4244