BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1953751 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24281
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    June 15, 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

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY INTERROGATED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. ENGINEERING CALCULATIONS DETERMINED THAT THIS DEVICE DID NOT MEET EXPECTED LONGEVITY. THE DEVICE'S LIFE CELL CAPACITY WAS LESS THAN EXPECTED. THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED TESTS WHICH VERIFIED FUNCTIONALITY, AND THERAPY DELIVERY. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO LOW-VOLTAGE CAPACITOR DEGRADATION, WHICH RESULTED IN A HIGH CURRENT CONDITION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CLINIC NURSE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS DEVICE TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI). TECHNICAL SERVICES WAS NOTIFIED THAT THIS DEVICE EXHIBITED A MONITORING VOLTAGE BELOW 2.65 VOLTS IN (B)(6) 2008. TECHNICAL SERVICES DISCUSSED DEVICE REPLACEMENT WITHIN 30 DAYS. THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE REMAINS IN-SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CLINIC NURSE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS DEVICE TRIGGERED ERI WITH A MONITORING VOLTAGE OF 2.50 VOLTS AND A CHARGE TIME OF 12.0 SECONDS. TECHNICAL SERVICES RECOMMENDED DEVICE REPLACEMENT WITHIN 30 DAYS OF ERI DECLARATION. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM AN IMPLANT FORM THAT THIS DEVICE WAS ELECTIVELY EXPLANTED AND WOULD BE RETURNED TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS. TO DATE, THE DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R T167| 0184| 4469