BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE FIXATION ENDOCARDIAL LEAD

    MDR report key: 780256 · Received November 10, 2006

    Report

    Report Number
    2017865-2006-01734
    Event Type
    Malfunction
    Date Received
    November 10, 2006
    Date of Event
    September 5, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEGMS SHOWED NON-PHYSIOLOGIC ACTIVITY. THE NOISE COULD NOT BE RECREATED CLINICALLY. BIPOLAR LEAD IMPEDANCE WAS 250-270 OHMS. UNIPOLAR LEAD IMPEDANCE WAS 272 OHMS. THE DEVICE WAS LEFT IN BIPOLAR PACE AND SENSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVE FIXATION ENDOCARDIAL LEAD PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1188T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR