BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 2083860 · Received May 11, 2011

    Report

    Report Number
    2017865-2011-02833
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    February 3, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 THE RIGHT ATRIAL LEAD EXHIBITED LOSS OF CAPTURE AT MAXIMUM OUTPUT. P WAVES MEASURED 0.2 MV. X-RAY CONFIRMED THAT THE LEAD HAD DISLODGED INTO THE RIGHT VENTRICLE. THE LEAD WAS REMOVED AND RE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention