BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1861063 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15213
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 29, 2010
    Report Date
    September 2, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC, CRM WILL ANALYZE THIS DEVICE UPON RECEIPT AND PROVIDE ADDITIONAL INFORMATION ONCE THE TESTING HAS BEEN COMPLETED, AND AN UPDATED REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DEVICE INTERROGATION REVEALED THAT THE DEVICE BATTERY STATUS WAS ELECTIVE REPLACEMENT INDICATOR (ERI), WITH A BATTERY VOLTAGE OF 2.30 VOLTS. A LONGEVITY CALCULATION CONFIRMED THAT THE DEVICE DID NOT MEET LONGEVITY ESTIMATES PROVIDED IN DEVICE LABELING. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. ALL LOW VOLTAGE POWER SUPPLY MEASUREMENTS WERE CURRENTLY WITHIN AN APPROPRIATE RANGE; HOWEVER, FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO TWO COMPROMISED LOW VOLTAGE CAPACITORS, WHICH RESULTED IN A HIGH CURRENT CONDITION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED AFTER THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS. ALSO, THE PHYSICIAN WAS DISSATISFIED WITH DEVICE LONGEVITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR T177