BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 4132230 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14417
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 19, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE PATIENT RECEIVED TWO SHOCKS ON THE SAME DAY. THE FOLLOWING DAY, THE PATIENT WAS PRESENTED FOR EVALUATION. UPON DEVICE INTERROGATION, A FAULT CODE, INDICATING EXTENDED CHARGE TIME MEASUREMENTS GREATER THAN 30 SECONDS WAS OBSERVED, ALONG WITH THE DEVICE DECLARING END OF LIFE (EOL). A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613120 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 0181| T180