BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 3210818 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07595
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 26, 2013
    Report Date
    June 3, 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 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND RETURNED UPON ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE REMAINS IMPLANTED. A DEVICE CHANGE OUT PROCEDURE HAS BEEN SCHEDULED. UPON EXPLANT, RETURN, AND ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE HAD TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI). UPON REVIEW OF THE DEVICE THERE WAS NO EVIDENCE THAT THE DEVICE DELIVERED EXCESSIVE THERAPY NOR THAT THE THERE WAS HIGH OUTPUT PACING. IT WAS SUSPECTED THAT THE DEVICE DECLARED ERI DUE TO CHARGE TIMES. PREMATURE BATTERY DEPLETION WAS ALLEGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311421 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1