BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 1050428 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01409
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    March 1, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN BIPOLAR THE ATRIAL LEAD EXHIBITED NO CAPTURE AT 7.5 V AND LEAD IMPEDANCE WAS GREATER THAN 2000 OHMS. LEAD IMPEDANCE WAS 290 OHMS IN UNIPOLAR AND CAPTURE WAS GOOD AT 1.0 V, 0.4 MS. PACING WAS PROGRAMMED TO UNIPOLAR AND SENSING WAS PROGRAMMED TO THE BIPOLAR CONFIGURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1