BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1771367 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12494
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 22, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL ANALYSIS DISCOVERED THAT THE DEVICE'S BATTERY CAPACITY WAS LESS THAN EXPECTED. THIS EVENT WILL BE UPDATED AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS PERFORMED AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THIS DEVICE HAD TWO COMPROMISED LOW-VOLTAGE CAPACITORS, WHICH RESULTED IN A HIGH CURRENT CONDITION. THIS ISSUE IS DISCUSSED IN THE Q2 2010 PRODUCT PERFORMANCE REPORT. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION, PER PROCEDURE PAPERWORK. A NEW BOSTON SCIENTIFIC DEVICE WAS SUCCESSFULLY IMPLANTED, WITH NO ADVERSE PATIENT EFFECTS REPORTED. THIS EXPLANTED DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR T175| 0185| E102