BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 1073207 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02020
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    April 1, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 THE PATIENT PRESENTED IN THE OFFICE COMPLAINING OF POCKET STIMULATION. THE PACEMAKER HAD BEEN PROGRAMMED TO UNIPOLAR ATRIAL PACING AT THE TIME. THE PACE- MAKER WAS PROGRAMMED TO BIPOLAR ATRIALPACING, BUT THE LEAD IMPEDANCE WAS NOTED TO BE GREATER THAN 2500 OHMS. AFTER A CHEST X-RAY, LEAD FRACTURE WAS SUSPECTED. THE DEVICE WAS THEN PROGRAMMED TO UNIPOLAR CONFIGURATION WITH A LOWER BASE RATE, AND HYSTERESIS ENABLED. THE DEVICE WILLBE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1488TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention