BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST JUDE TENDRIL ST 1788TC/46CM

    MDR report key: 1192185 · Received October 8, 2008

    Report

    Report Number
    MW5008572
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 30, 2008
    Report Date
    September 30, 2008
    Manufacturer
    ST. JUDE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEW DUAL CHAMBER PPM IMPLANT. ST JUDE TENDRIL ST LEAD INSERTED IN THE ATRIUM ACTIVELY AFFIXED INITIAL NUMBERS IMPEDANCE WNL AND STABLE, HOWEVER, UNABLE TO CAPTURE AT 2 VOLTS. SECOND ATTEMPT WITH MEASUREMENTS INDICATED HIGH IMPEDANCES OVER 2000 OHMS. MULTIPLE CONFIGURATION WITH THE PSA CABLE WERE ATTAINED ALL WITH HIGH IMPEDANCES. THE LEAD WAS REMOVED AND A NEW LEAD INSERTED IN THE ATRIUM WITH SATISFACTORY RESULTS, NO HARM TO PT. THE LEAD WAS NOTED TO HAVE BLOOD APPARENT IN THE LEAD UNDER THE INSULATION NEAR THE HELIX PORTION. NOT APPARENT OR VISIBLE TO THE EYE BREAKS IN THE INSULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE TENDRIL ST 1788TC/46CM ST JUDE TENDRIL ST 1788TC/46CM DTB ST. JUDE

    Patients

    Seq Age Sex Outcome Treatment
    1