BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 1073364 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02153
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    May 12, 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
    WA
    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 OVERSENSING AND PAUSES WERE OBSERVED ON THE ECG STRIPS. ISOMETRICS AND ARM EXERCISES WERE SUCCESSFUL IN RECREATING INHIBITION IN BIPOLAR SENSING. THE LEAD WOULD REMAIN IN THE BIPOLAR CONFIGURATION. THE PATIENT WOULD CONTINUE TO BE FOLLOWED-UP.

    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 1688TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1