BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL DX

    MDR report key: 1073476 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02255
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 27, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 A FRACTURE OF THE ATRIAL LEAD WAS SUS- PECTED DUE TO LOW LEAD IMPEDANCE MEASUREMENTS, NOISE ON THE ATRIAL CHANNEL AND LOSS OF CAPTURE.

    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 1388T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention