BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 3040833 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00176
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    October 4, 2010
    Report Date
    January 4, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A LONGEVITY CALCULATION CONFIRMED THE DEVICE DID NOT MEET LONGEVITY ESTIMATES PROVIDED IN DEVICE LABELING. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THE PREMATURE BATTERY DEPLETION WAS DUE TO LOW-VOLTAGE CAPACITOR DEGRADATION, WHICH RESULTED IN A HIGH CURRENT CONDITION. (B)(6) REMAINS IMPLANTED/INCREASED DEVICE FOLLOW-UP ADVISED: TECHNICAL SERVICES ADVISED THAT THE DEVICE FOLLOW-UP INTENSIFY TO MONTHLY. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. AT THIS TIME, RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE DID NOT MEET A PORTION OF THE INITIAL TESTING. ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI), WITH A CHARGE TIME MEASUREMENT OF 21 SECONDS AND A MONITORING VOLTAGE MEASUREMENT OF 2.42 V. IT WAS DISCUSSED THAT ERI LIKELY DECLARED AS A RESULT OF CHARGE TIME MEASUREMENT. APPROXIMATELY TWO YEARS LATER, THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. THE DEVICE WAS THEN RETURNED TO ALLOW FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143443 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 1850| 0144| T175