BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 1050523 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01499
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 23, 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
    CA
    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 THREE DAYS POST IMPLANT, THE LEAD EXHIBITED LOSS OF VENTRICULAR CAPTURE IN BOTH CONFIGURATIONS. THE LEAD WAS REPOSITIONED. HOWEVER, ONE DAY LATER, LOSS OF VENTRICULAR CAPTURE WAS AGAIN NOTED IN BOTH CONFIGURATIONS. LEAD IMPEDANCE WAS 296 OHMS IN THE UNIPOLAR CONFIGURATION. AN X-RAY REVEALED NO MOVEMENT OF THE LEAD. THE DEVICE WAS LEFT AT THE PREVIOUS SETTINGS AND THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention