BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THINLINE EZ

    MDR report key: 216300 · Received March 19, 1999

    Report

    Report Number
    1640319-1999-00309
    Event Type
    Malfunction
    Date Received
    March 19, 1999
    Date of Event
    March 12, 1999
    Manufacturer
    INTERMEDICS INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT DURING THE IMPLANT, WHEN MEASURING THE LEAD IMPEDANCE WITH A "PSC" UNDER THE BIPOLAR CONFIGURATION, 2000-3000 OHMS OF LEAD IMPEDANCE WERE MEASURED; IN THE UNIPOLAR MODE, THE SAME MEASUREMENT WAS OBTAINED. WHEN CONNECTING THE LEAD WITH THE PACER AND ACQUIRING TELEMETRY, "HIGH OMHS" WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE EZ Implant PACEMAKER LEAD DTB INTERMEDICS INC. 438-10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 294-09 (PACER).