BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY VR

    MDR report key: 1000492 · Received February 8, 2008

    Report

    Report Number
    2124215-2008-99858
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    November 23, 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 ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT 23.0 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, ERI 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 (NOVEMBER 27, 2007) ADVISORY POPULATION. THIS ISSUE IS DISCUSSED IN THE Q4 2007 PRODUCT PERFORMANCE REPORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED THE ELECTIVE REPLACEMENT INDICATOR (ERI). THERE WAS A CONCERN THAT THE BATTERY DEPLETED EARLIER THAN EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CLONMEL 1870

    Patients

    Seq Age Sex Outcome Treatment
    1 Other T177/111445| 0161/101210