BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 537984 · Received August 3, 2004

    Report

    Report Number
    537984
    Event Type
    Malfunction
    Date Received
    August 3, 2004
    Date of Event
    June 9, 2004
    Report Date
    July 30, 2004
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PACEMAKER INITIALLY PLACED IN 1999. PT STARTED EXPERIENCING INCREASED PACING THRESHOLDS, SENSING DIFFICULTY AND INTERMITTENT CAPTURE. AFTER SEVERAL STUDIES AND ADJUSTMENTS MADE TO THE 1 PG MD DECIDED TO EXPLANT THE LEAD AND RE-IMPLANT AND POSITION THE VENTRICULAR LEAD IN A DIFFERENT PLACE IN THE RV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC VENTRICULAR LEAD LWS MEDTRONIC, INC. 5054 *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other