BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY DR

    MDR report key: 1000494 · Received February 8, 2008

    Report

    Report Number
    2124215-2008-99859
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    November 28, 2007
    Report Date
    February 7, 2008
    Manufacturer
    CLONMEL
    Product Code
    LWS
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONCLUSION A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED END OF LIFE (EOL) AFTER EXPERIENCING ONE CHARGE TIME GREATER THAN 30 SECONDS. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, EOL WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. THIS DEVICE IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS (IN 2007) ADVISORY POPULATION.

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTED 53 MONTHS, DISPLAYED THE END OF LIFE INDICATOR (EOL). THERE WAS A CONCERN THAT THE BATTERY DEPLETED EARLIER THAN EXPECTED. THE BATTERY STATUS WAS 2,58 V AND THE CHARGE TIME WAS 32,8 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CLONMEL 1871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 0148| T167| 4096