BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2171008 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10053
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN TO BOSTON SCIENTIFIC, 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. ANALYSIS OF THIS DEVICE CONCLUDES INVESTIGATION. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH IS PART OF THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS PRODUCT UPDATE CLASSIFIED AS A PRODUCT ADVISORY AND INITIALLY COMMUNICATED ON (B)(6) 2007, DISPLAYED A BATTERY STATUS OF ELECTIVE REPLACEMENT INDICATOR (ERI) WITH A CHARGE TIME OF 20.15 SECONDS AT A MONITORING VOLTAGE OF 2.67 VOLTS PER BOSTON SCIENTIFIC (B)(4) LABORATORY ANALYSIS. END OF LIFE (EOL) WAS DECLARED WITH A CHARGE TIME OF 45.121 SECONDS AT A MONITORING VOLTAGE OF 2.65 VOLTS. THE DEVICE HAD BEEN CHANGED OUT FOR NORMAL BATTERY DEPLETION WITHOUT COMPLICATION AND THERE HAD BEEN NO REPORT OF ADVERSE PATIENT EFFECT.

    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 63 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)