BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1945012 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19753
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    October 1, 2010
    Report Date
    November 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS MEDICAL DEVICE REMAINS ACTIVELY IN SERVICE. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) 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. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE AND THE RESULTS INDICATED THE MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE AND PROGRAMMED SETTINGS. IT WAS 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 BUILDUP 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

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REVEALED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND WAS REPLACED WITH A NEW DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE, WHICH IS NOT ASSOCIATED WITH ANY ADVISORY POPULATION, DID REACH MIDDLE OF LIFE (MOL2) FROM BEGINNING OF LIFE (BOL) WITHIN THREE MONTHS TIME. THE CHARGE TIME MEASUREMENT WAS 11.8 SECONDS. THERE WAS CONCERN FOR BATTERY DEPLETION ANOMALY. THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T125

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 4470| 0185| T125