BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2911248 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15911
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    February 21, 2007
    Report Date
    November 27, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 APPROXIMATELY FIVE YEARS AGO THAT NO TONES WERE HEARD WHEN A MAGNET WAS APPLIED TO THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE DEVICE WAS INTERROGATED AND ALL PROGRAMMING SEEMED CORRECT. BEEP ON PACED AND SENSED EVENTS WAS PROGRAMMED ON AND NO BEEPING WAS HEARD. BEEP ON CHARGE WAS PROGRAMMED AND A MANUAL CAPACITOR REFORMATION WAS COMPLETED. BEEPING WAS HEARD AND, SUBSEQUENTLY, BEEPING WAS HEARD WITH BEEP ON PACED AND SENSED EVENTS PROGRAMMED ON AND WITH THE APPLICATION OF A MAGNET. THIS DEVICE WAS RECENTLY EXPLANTED FOR NORMAL BATTERY DEPLETION (NBD) AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18911 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 0181| T167| 4087