BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL DX

    MDR report key: 804419 · Received January 10, 2007

    Report

    Report Number
    2017865-2007-00080
    Event Type
    Malfunction
    Date Received
    January 10, 2007
    Date of Event
    November 1, 2006
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BIPOLAR ATRIAL LEAD IMPEDANCE WAS 1032 OHMS AND THE UNIPOLAR IMPEDANCE WAS 236 OHMS. THE BIPOLAR CAPTURE THRESHOLD WAS 2.75 V AND SENSING WAS 2 MV. AT A FOLLOW-UP SIX MONTHS PREVIOUS, BIPOLAR IMPEDANCE WAS 745 OHMS, THE CAPTURE THRESHOLD WAS 1.75 V, AND THE SENSING THRESHOLD WAS 3.5 MV. X-RAY CONFIRMED A LEAD FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL DX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1388TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR