BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2171620 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-11062
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) WITH A CHARGE TIME OF 22 SECONDS. IT WAS ALLEGED THE DEVICE HAD REACHED ERI EARLIER THAN EXPECTED. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention