BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1852612 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14215
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 14, 2010
    Report Date
    August 6, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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, ERI WAS REACHED EARLIER THAN EXPECTED 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.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. WHEN THE DEVICE HAS BEEN EXPLANTED AND RETURNED, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    A REPLACEMENT PROCEDURE WAS PERFORMED, THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DEVICE REPORTED BEEPING TONES. INTERROGATION REVEALED THE DEVICE HAD REACHED END OF LIFE (EOL) STATUS. THIS DEVICE IS IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS PRODUCT ADVISORY COMMUNICATED ON MARCH 10, 2007. THIS DEVICE IS DISPLAYING THE SYMPTOMS OF THAT ADVISORY. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND RECOMMENDED DEVICE REPLACEMENT IN THE NEAR FUTURE. 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 1871

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 0158| 1871| 4087