BEUDAMED
    FDA Adverse Event Death Summary report: N

    PY PACING LEAD

    MDR report key: 303366 · Received November 3, 2000

    Report

    Report Number
    1035166-2000-00125
    Event Type
    Death
    Date Received
    November 3, 2000
    Date of Event
    August 17, 2000
    Report Date
    November 3, 2000
    Manufacturer
    OSCOR, INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 2000, PT EXPERIENCED SYNCOPAL EPISODE DUE TO INTERMITTENT LOSS OF CAPTURE AS A RESULT OF LEAD MICRODISLODGEMENT. INTERROGATION OF THE DEVICE THE NEXT DAY FOUND IT TO BE APPROPRIATELY CAPTURING. HOWEVER, THE PT PASSED AWAY TWO WEEKS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PY PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR, INC. PY 52 PSBV 2P8

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H