BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 1771540 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12832
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 11, 2010
    Report Date
    June 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. THIS DEVICE IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS (NOVEMBER 27, 2007) ADVISORY POPULATION. THIS ISSUE IS DISCUSSED IN THE Q2 2010 PRODUCT PERFORMANCE REPORT.

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES DISCUSSED THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY AND THAT IT APPEARED THIS BEHAVIOR HAD NOT MANIFESTED ITSELF IN THIS DEVICE IN (B)(6). REPLACEMENT WAS RECOMMENDED. THE CLINICIAN CONFIRMED THAT THE DEVICE WAS BEING REPLACED THAT DAY. ANOTHER BOSTON SCIENTIFIC ICD WAS IMPLANTED. THE EXPLANTED DEVICE WAS RETURNED AND IS UNDERGOING LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A MONITORING VOLTAGE OF 2.84V WITH A CHARGE TIME OF 15 SECONDS IN (B)(6) 2009. TECHNICAL SERVICES HAD INDICATED THESE WERE NORMAL VALUES AT THAT TIME. THE DEVICE DECLARED END OF LIFE (EOL) BATTERY STATUS IN (B)(6) 2010 WITH A MONITORING VOLTAGE OF 2.66V WITH A CHARGE TIME OF 30 SECONDS. THE CLINICIAN QUESTIONED WHY EOL WAS DECLARED SO SOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T127

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention E110| 4243| T127| 1831| 0125