BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 3041052 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00566
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REMOVAL, THIS DEVICE WILL BE RETURNED TO THE POST MARKET QUALITY ASSURANCE LABORATORY AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPORTED HEARING THE DEVICE BEEPING FOR APPROXIMATELY TWO WEEKS. INTERROGATION REVEALED THIS DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO AN EXTENDED CHARGE TIME OF 27 SECONDS. BATTERY VOLTAGE WAS 2.66V. APPROXIMATELY FOUR MONTHS EARLIER, INTERROGATION HAD REVEALED BATTERY VOLTAGE AT BEGINNING OF LIFE (BOL) AND CHARGE TIME OF 7.7 SECONDS. THERE WAS CONCERN THAT THE BATTERY DEPLETED MORE RAPIDLY THAN EXPECTED. A REPLACEMENT PROCEDURE WILL BE PERFORMED IN THE FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142784 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1