BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY AVT

    MDR report key: 816100 · Received February 8, 2007

    Report

    Report Number
    2124215-2007-19419
    Event Type
    Malfunction
    Date Received
    February 8, 2007
    Date of Event
    November 3, 2006
    Report Date
    November 3, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z1107-9/05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED AN ELECTIVE REPLACEMENT INDICATOR (ERI). THERE IS A CONCERN THAT THE BATTERY DEPLETED EARLIER THAN EXPECTED. THE MONITORING VOLTAGE WAS 2.66 V WITH A CHARGE TIME OF 28.4 SECONDS. THIS DEVICE IS PART OF THE AVT LATCHING POPULATION (6/17/2005).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT IMPLANTABLE ATRIAL GENERATOR LWS CARDIAC PACEMAKERS, INC A135 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other