BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2171615 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10087
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 DISPLAYED ITS END OF LIFE (EOL) INDICATOR DUE TO AN EXTENDED CHARGE TIME THAT MAY HAVE EXCEEDED SPECIFICATIONS. THERE WAS CONCERN THAT THE DEVICE DID NOT TRIGGER AN ELECTIVE REPLACEMENT INDICATOR (ERI) PRIOR TO DECLARING EOL. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED ONE DAY LATER DUE TO NORMAL BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 0125| 1748| 1852| T180