BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 3923419 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14716
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 21, 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
    CA, US
    Reporter Occupation
    OTHER

    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 AN ASYMPTOMATIC PATIENT WAS PRESENTED IN CLINIC FOR A ROUTINE FOLLOW-UP AND THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE. THE NOISE COULD NOT BE REPRODUCED THROUGH ISOMETRICS. NO PROGRAMMING CHANGES WERE MADE AND THE PATIENT WOULD CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399790 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1788TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR