BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3212588 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09168
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 6, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    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. THE DEVICE AND BATTERY BEHAVIOR MATCH THAT OF TRENDED UNITS THAT REACH ERI/EOL PREMATURELY DUE TO A HIGHER THAN EXPECTED CELL IMPEDANCE INCREASE.

    Additional Manufacturer Narrative · 1

    WHEN THE DEVICE HAS BEEN REMOVED AND RECEIVED AT THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PROVIDED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE REPORTED THEIR DEVICE BEEPING. DURING A FOLLOW UP VISIT, INTERROGATION REVEALED ELECTIVE REPLACEMENT INDICATOR (ERI) HAD BEEN REACHED EARLIER THAN EXPECTED. A REPLACEMENT PROCEDURE IS INTENDED. UPON REMOVAL, THE DEVICE WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312049 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R