BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 3923999 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14932
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 1, 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
    NC, 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 THE PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. THE ATRIAL LEAD EXHIBITED NOISE, AND MULTIPLE EPISODES OF SHORT AUTO MODE SWITCH DUE TO LOW INTERMITTENT NOISE WERE NOTED. THE NOISE COULD BE REPRODUCED BY ARM MOVEMENT. THE DEVICE WAS REPROGRAMMED AND THE PATIENT WOULD CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401516 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR