BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 16774852 · Received April 20, 2023

    Report

    Report Number
    2017865-2023-18034
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    March 27, 2023
    Report Date
    April 20, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734501750
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-18033. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER AND ATRIAL LEAD EXHIBITED INAPPROPRIATE MODE SWITCH DUE TO NOISE OVERSENSING. PROGRAMMING CHANGES WERE MADE AND THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613298 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1888TC/52 4034190 05414734501750

    Patients

    Seq Age Sex Outcome Treatment
    1 Male TENDRIL ST