BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1861050 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15282
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 27, 2010
    Report Date
    November 3, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1620-09 TO Z-1621-09
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS ELECTIVELY EXPLANTED IN (B)(6) 2011. TO DATE, THE DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC RETURN PRODUCTS DEPARTMENT. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED AND/OR THE DEVICE IS RETURNED FOR LABORATORY TESTING.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A LONGEVITY CALCULATION CONFIRMED THAT THE DEVICE DID MEET LONGEVITY ESTIMATES PROVIDED IN DEVICE LABELING. HOWEVER, THE DEVICE'S LIFE CELL CAPACITY WAS LESS THAN EXPECTED. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO A COMPROMISED LOW-VOLTAGE CAPACITOR, WHICH RESULTED IN A HIGH CURRENT CONDITION. IN SPITE OF THIS COMPROMISED CAPACITOR, TESTING CONFIRMED THAT THE DEVICE HAD NORMAL PACING, SENSING, AND DEFIBRILLATION THERAPY FUNCTIONS.

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE REMAINS IN-SERVICE. THE EVENT WILL BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE IS RETURNED FOR LABORATORY TESTING.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE, AT 33 MONTHS, WAS EXHIBITING A MONITORING VOLTAGE OF 2.61 VOLTS. THE CLINIC NURSE ASKED FOR RECOMMENDATIONS FOR DEVICE FOLLOW-UP. TECHNICAL SERVICES ADVISED THAT THIS DEVICE SHOULD BE FOLLOWED ON THE PATIENT'S LATITUDE MONITORING SYSTEM EVERY MONTH UNTIL ELECTIVE REPLACEMENT INDICATOR (ERI) IS TRIGGERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R 0185| T167| 5076