BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 1950275 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22319
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 15, 2010
    Report Date
    December 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ICD MEMORY WAS REVIEWED. WE CONFIRMED THAT THE DEVICE DECLARED ON (B)(6) 2010 WITH A CHARGE TIME OF 24.49 SECONDS AT A MONITORING VOLTAGE OF 2.78 VOLTS. EOL WAS DECLARED ON (B)(6) 2010 WITH A CHARGE TIME OF 32.46 SECONDS AT A MONITORING VOLTAGE OF 2.74 VOLTS. THE MAXIMUM CHARGE TIME WHILE IMPLANTED WAS 32.46 SECONDS. TO DETERMINE IF THE DEVICE'S RATE OF BATTERY DEPLETION WAS NORMAL, OUR TECHNICIANS COMPARED THE OBSERVED RATE OF BATTERY USAGE TO THE EXPECTED RATE OF BATTERY USAGE. THE RESULTS SHOWED THAT THE MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE TO DATE AND PROGRAMMED SETTINGS. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, EOL WAS TRIGGERED EARLIER THAN EXPECTED BY CHARGE TIMES IN EXCESS OF THE RESPECTIVE CHARGE TIME LIMITS. LABORATORY TECHNICIANS AND ENGINEERS CONCLUDED THAT THIS DEVICE DID NOT EXPERIENCE PREMATURE BATTERY DEPLETION. RATHER, AN EOL CHARGE TIME REPLACEMENT INDICATOR WAS DECLARED DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE DISPLAYED OVERSENSING CAUSING AN INAPPROPRIATE SHOCK. IN ADDITION, THIS DEVICE REACHED END OF LIFE APPROXIMATELY TWO MONTHS EARLIER DUE TO CHARGE TIME OF 32.3 SECONDS. THERE WAS CONCERN THAT THE BATTERY DEPLETED MORE RAPIDLY THAN EXPECTED. A REPLACEMENT PROCEDURE WAS PERFORMED, THIS DEVICE WAS REMOVED, REPLACED AND WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1870

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention