BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1954146 · Received January 10, 2011

    Report

    Report Number
    2124215-2011-00443
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 25, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN ANALYSIS IS COMPLETE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. SHOULD THIS DEVICE GET RETURNED OR SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WOULD BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, 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. LABORATORY ANALYSIS WAS ABLE TO CONFIRM THE CLINICAL OBSERVATIONS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI). A HEALTH CARE PROVIDER CALLED TECHNICAL SERVICES INQUIRING ABOUT THE ANALYSIS OF THIS DEVICE AND NOTED THE BATTERY VOLTAGE TOOK A "NOSEDIVE" LATER IN THE DEVICE LIFE. TECHNICAL SERVICES CONFIRMED THE DEVICE HAD NOT BEEN RETURNED TO OUR COMPANY FOR ANALYSIS TO THIS DATE.

    Description of Event or Problem · 1

    THE DEVICE HAS SINCE BEEN RETURNED AND IS CURRENTLY IN ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention T177| 0185| E102