BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 3924020 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14960
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 DURING THE IMPLANT PROCEDURE THE RIGHT ATRIAL LEAD CONNECTOR COULD NOT BE INSERTED IN THE DEVICE HEADER. UPON EXAMINING THE LEAD, IT WAS NOTED THAT THE SEALING RING WAS PARTIALLY PUSHED OVER THE RING ELECTRODE, INTERFERING WITH LEAD INSERTION. THE PHYSICIAN REMOVED THE SEALING RING AND WAS ABLE TO INSERT THE LEAD INTO THE DEVICE HEADER. ALL ELECTRICAL MEASUREMENTS WERE NORMAL AND THE LEAD REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400562 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR