BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEAD

    MDR report key: 561417 · Received January 16, 2004

    Report

    Report Number
    561417
    Event Type
    Other
    Date Received
    January 16, 2004
    Date of Event
    September 23, 2003
    Report Date
    January 16, 2004
    Manufacturer
    MEDTRONIC
    Product Code
    DSA
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RECEIVED DOCUMENT FROM MEDTRONIC THAT SMDA REPORT WAS NECESSARY. LEAD HAD LOW IMPEDENCE AND NO CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD LEAD WIRE DSA MEDTRONIC 6944 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR