BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 6970867 · Received October 24, 2017

    Report

    Report Number
    2017865-2017-33525
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    September 21, 2017
    Report Date
    October 23, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC. LOSS OF CAPTURE WAS NOTED ON THE ATRIAL LEAD. THE DEVICE HAD MULTIPLE NON SUSTAINED OVERSENSING EPISODES (NSO) AND WAS OVERSENSING SIGNALS THAT APPEARED TO BE MYOPOTENTIALS ON THE VENTRICULAR CHANNEL. ATRIAL LEAD OUTPUT WAS INCREASED. PROGRAMMING CHANGES WERE DONE TO ADDRESS NSO AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752656 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/52 P000018954

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR