BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1945618 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-19890
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    August 11, 2008
    Report Date
    October 11, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THAT ELECTIVE REPLACEMENT INDICATOR (ERI) WAS DECLARED AFTER EXPERIENCING TWO CHARGE TIMES GREATER THAN THE CHARGE TIME LIMIT. END OF LIFE (EOL) WAS DECLARED FOLLOWING A SINGLE CHARGE TIME GREATER THAN 30 SECONDS. TO DETERMINE IF THE DEVICE'S RATE OF BATTERY DEPLETION WAS WITHIN NORMAL LIMITS, 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 AND PROGRAMMED SETTINGS. LABORATORY TECHNICIANS AND ENGINEERS CONCLUDED THAT THIS DEVICE DID NOT EXPERIENCE PREMATURE BATTERY DEPLETION. RATHER, THE ERI TO EOL TIME PERIOD WAS SHORTENED DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. THE DEVICE WAS CAPABLE OF DETECTING AND TREATING ARRHYTHMIAS, AS THE BATTERY ITSELF HAD SUFFICIENT CAPACITY REMAINING TO PROVIDE THERAPY IF NEEDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED WITH NO ALLEGATIONS. INITIAL LABORATORY ANALYSIS CONFIRMED THAT THIS DEVICE WAS OUT OF SPECIFICATION DUE TO A SHORTENED ELECTIVE REPLACEMENT INDICATOR (ERI) TO END OF LIFE (EOL) TIME. DETAILED DEVICE ANALYSIS WILL BE CONDUCTED AT WHICH TIME THIS EVENT WILL BE UPDATED. 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 53 YR (B)(4)| (B)(4)