BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 1050369 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01355
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    February 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
    PA
    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 LEAD IMPEDANCE WAS LESS THAN 200 OHMS IN BOTH CONFIGURATIONS. UNIPOLAR CAPTURE THRESHOLD WAS AT 1.25 V, 0.4 MS AND BIPOLAR CAPTURE WAS AT 1.75 V, 0.4 MS WITH AN 8.9 MV R-WAVE. THE PATIENT HAD PECTORAL STIMULATION AT OUTPUTS OF 5.0 V AND EXPERIENCED A RUN OF TORSADE DE POINTES PRIOR TO THE FOLLOW-UP. THE PULSE GENERATOR WILL REMAIN PROGRAMMED TO UNIPOLAR PACE AND BIPOLAR SENSE WITH THE VENTRICULAR OUTPUT PROGRAMMED TO 5.0 V, 0.8 MS.

    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 1688T/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1