BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 23276733 · Received October 15, 2025

    Report

    Report Number
    2017865-2025-1002547
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 22, 2025
    Report Date
    October 27, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734502887
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: PLEASE RETRACT THIS REPORT 2017865-2025-1002547 AS RESPONSE FROM THE REPRESENTATIVE RECEIVED CONFIRMS THERE'S NO ALLEGATION OF MALFUNCTION AGAINST THE RIGHT VENTRICULAR LEAD BUT RATHER THE PACEMAKER AS REPORTED IN 2017865-2025-1002546.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED LOSS OR CAPTURE AND INTERMITTENT VENTRICULAR CAPTURE ON AUTOMATED MODE SWITCH (AMS) EPISODES ON THE RIGHT VENTRICULAR (RV) LEAD AND PACEMAKER. NO PATIENT SYMPTOMS OR INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2597357 TENDRIL STS NO MATCH NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/52 P000156918 05414734502887

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female 2088TC/46 TENDRIL RIGHT ATRIAL LEAD