BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1952545 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23238
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1513-08 TO Z-1514-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DETAILED ANALYSIS THIS EVENT WILL BE UPDATED AND FILED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, DEVICE MEMORY WAS REVIEWED. WE CONFIRMED THAT THE DEVICE DECLARED ERI AFTER EXPERIENCING ONE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT OF 18.9 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, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY CHARGE TIMES IN EXCESS OF THE 18.9 SECOND EXTENDED ERI CHARGE TIME LIMIT. LABORATORY TECHNICIANS AND ENGINEERS CONCLUDED THAT THIS DEVICE DID NOT EXPERIENCE PREMATURE BATTERY DEPLETION. RATHER, AN ERI CHARGE TIME REPLACEMENT INDICATOR WAS DECLARED DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED WITH NO ALLEGATIONS. INITIAL ANALYSIS SHOWED THAT THE ICD FAILED LONGEVITY CALCULATION. FURTHER ANALYSIS WILL BE CONDUCTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    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