BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KY-V

    MDR report key: 110056 · Received July 30, 1997

    Report

    Report Number
    1035166-1997-00055
    Event Type
    Injury
    Date Received
    July 30, 1997
    Date of Event
    January 9, 1996
    Report Date
    June 30, 1997
    Manufacturer
    SULZER OSCOR INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ALLEGED FAILURE OF ATRIAL LEAD CAUSED PT INJURY. SOURCE OF REPORT PLAINTIFFS ATTORNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KY-V Implant FIXED SCREW-IN DTB SULZER OSCOR INC. KY-V 2G7

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention