BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 225687 · Received June 1, 1999

    Report

    Report Number
    225687
    Event Type
    Injury
    Date Received
    June 1, 1999
    Date of Event
    May 28, 1999
    Report Date
    June 1, 1999
    Manufacturer
    VASCOR MEDICAL
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VASCOR MODEL 111-256, BIPOLAR IMPEDANCE AT IMPLANT, MEASURED 510 OHMS ON 11/12/96. BIPOLAR IMPEDANCE SLOWLY CLIMBED AS FOLLOWS: 12/3/96 - 640 OHMS; 12/31/96 - 739 OHMS; 2/11/97 - 785 OHMS; 5/20/97 - 945 OHMS. IMPEDANCE HAS SLOWLY BEEN DECLINING SINCE REACHING A HIGH OF 945 OHMS. RANGED FROM 914 OHMS TO 843 OHMS 2/12/99, AND 811-836 OHMS FROM 8/11/97 - 2/12/99. IMPEDANCES BIPOLAR ON 5/28/99 MEASURED 778-826 OHMS. PT IS TOTALLY PACEMAKER DEPENDENT. WILL REPLACE THE LEAD PRIOR TO FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant VENTRICULAR PACING LEAD DTB VASCOR MEDICAL 111-256 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening