BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 1951003 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22934
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-08 TO Z-0053-08
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ALLEGATION AGAINST DEVICE FUNCTIONALITY. THE SYSTEM WAS EXPLANTED SECONDARY DUE TO PATIENT INFECTION. INVESTIGATION IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFBRILLATOR (ICD) AND ASSOCIATED TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD OF THE PATIENT'S DEVICE SYSTEM WAS EXPLANTED DUE TO POCKET INFECTION. A NEW DEVICE SYSTEM MAY BE IMPLANTED ONCE THE PATIENT IS CLEARED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T135

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 1793| 0144| T135