BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANSVENE SVC/CS

    MDR report key: 2090434 · Received May 16, 2011

    Report

    Report Number
    2182208-2011-00680
    Event Type
    Death
    Date Received
    May 16, 2011
    Date of Event
    February 4, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980050/S1
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY THREE MONTHS POST THE IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENE SVC/CS IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6937A ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death