BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PY PACING LEAD

    MDR report key: 147864 · Received February 8, 1998

    Report

    Report Number
    1035166-1998-00002
    Event Type
    Injury
    Date Received
    February 8, 1998
    Date of Event
    May 21, 1992
    Report Date
    January 8, 1998
    Manufacturer
    SULZER OSCOR INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "PULSE GENERATOR APPROACHING END OF LIFE. FLUID NOTED IN HEADER OF EXPLANTED LEAD. UNABLE TO DUPLICATE NOISE NOTED ON 5/19/1992."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PY PACING LEAD Implant RETRACTABLE SCREW-IN PACING LEAD DTB SULZER OSCOR INC. PY-BV 1G8

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention