BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL DX

    MDR report key: 1050367 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01353
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    February 26, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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

    THE PATIENT PRESENTED TO THE CLINIC AFTER HAVING SYNCOPAL EPISODES. HIGH RATE SEGMS REVEALED NOISE ON THE VENTRICULAR CHANNEL WHICH WAS REPRODUCED WHEN THE PATIENT TOUCHED HIS TOES. CAPTURE THRESHOLDS WERE 4 V AT O.8 MS. OVERSENSING WAS NOTED IN THE UNIPOLAR CONFIGURATION. THE PATIENT WAS PACED IN THE ATRIUM ABOUT 99 PERCENT OF THE TIME WITH INTACT VENTRICULAR CONDUCTION. THE DEVICE WAS PROGRAMMED TO THE AAIR MODE.

    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/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1