BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC INC.

    MDR report key: 270631 · Received March 16, 2000

    Report

    Report Number
    270631
    Event Type
    Malfunction
    Date Received
    March 16, 2000
    Date of Event
    February 15, 2000
    Report Date
    February 15, 2000
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT CAME TO SURGERY FOR PACEMAKER GENERATOR CHANGE BUT LEAD (VENTRICULAR) WAS CAPPED AND LEFT IN PLACED AND INSERTED ANOTHER VENTRICULAR LEAD DUE TO HIGH THRESHOLDS. IMPLANTED VENTRICULAR LEAD 5092-52.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INC. VENTRICULAR LEAD DTB MEDTRONIC INC. 4024-52 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other