BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 3040812 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-03362
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 A NON-BSC RIGHT VENTRICULAR (RV) LEAD SHORTED THE DEVICE SYSTEM. A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED AND REPLACED WITH A PACEMAKER SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143430 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T127

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R T127| 4470| 6949| MISMATCH