BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY AVT

    MDR report key: 1863646 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15585
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 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

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO EXTENDED CHARGE TIME. MONITORING VOLTAGE WAS 2.54 V AND CHARGE WAS 27.6 SECONDS. THIS DEVICE IS PART OF THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY. DEVICE REPLACEMENT WAS PLANNED FOR THE FOLLOWING WEEK AND THE CALLER WONDERED IF THIS WAS OK. TECHNICAL SERVICES DISCUSSED THAT THIS SHOULD BE OK. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND A155

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR 1488T| 0157| A155