BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3252021 · Received July 29, 2013

    Report

    Report Number
    2124215-2013-11884
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, 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 BUILDUP OF INTERNAL BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) WITHIN WARRANTY PERIOD. THE PATIENT WAS NOT MONITORED AND THE DEVICE WAS PROGRAMMED AT ACUTE OUTPUTS SINCE IMPLANT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) BELIEVED THE DEVICE REACHED ERI SOONER THAN EXPECTED BECAUSE OUTPUTS WERE SET HIGH LIKE THEY ARE FOR NEW IMPLANTS. THE DEVICE WAS EXPLANTED AND OUT OF SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352628 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| L| R T167| E143| 4469| 0185