BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 1043440 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33201
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 6, 2008
    Report Date
    January 2, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    Removal / Correction Number
    Z47/55-07
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH IS PART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY, ORIGINALLY COMMUNICATED (B)(6) 2007, HAD A MONITORING BATTERY VOLTAGE OF 2.62 V AFTER 27 MONTHS OF IMPLANT. THE DEVICE REMAINED IMPLANTED FOR OVER FOUR YEARS AFTER THIS INITIAL ALLEGATION, UNTIL INFORMATION WAS RECENTLY RECEIVED THAT THE DEVICE WAS EXPLANTED AND REPLACED WITH A COMPETITOR'S DEVICE. NO INFORMATION COULD BE OBTAINED ABOUT THE REPLACEMENT OR IF THE DEVICE WILL BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| O| R THE DEVICE 4470/419515 WAS IMPLANTED 25-OCT-2005| THE DEVICE 4470/419515| THE DEVICE 0185/119621| THE DEVICE 0185/119621 WAS IMPLANTED 25-OCT-2005