BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 25179284 · Received May 14, 2026

    Report

    Report Number
    2017865-2026-10143
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    October 22, 2025
    Report Date
    May 14, 2026
    Manufacturer
    ABBOTT MEDICAL (CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734502894
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT #1 PI MAIN [PI-2025-0172246-01]. AN EVENT OF INCORRECT, INADEQUATE OR IMPRECISE RESULT OR READINGS, PACING PROBLEM, AND BREAK RESULTING IN NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS WHICH WAS ADDRESSED BY AN ADDITIONAL SURGICAL PROCEDURE WAS REPORTED. THE LOW VOLTAGE LEAD IS EXPLANTED AND IS NOT EXPECTED TO BE RETURNED. GFES WERE PERFORMED TO CONFIRM IF THE NOISE RESULTED IN OVERSENSING AND IF IMAGING WAS PERFORMED AND THE RESULTS. INFORMATION RECEIVED INDICATED, NOISE REVERSION WAS NOTED RESULTING IN INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS) AND IMAGING WAS PERFORMED; NO ANOMALIES WERE NOTED. THE LEAD WAS EXPLANTED AND REPLACED TO RESOLVE THIS EVENT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT REQUIRED PER INVESTIGATION PROCEDURE. THE REPORTED EVENT OF NOISE AND AMS WERE CONFIRMED BY A FIELD REPRESENTATIVE VIA DEVICE RECORDS. LEAD INSULATION DAMAGE WAS ALLEGED, BUT THIS WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED FOR SUSPECTED INSULATION DAMAGE. X-RAY IMAGING WAS PERFORMED; NO ANOMALIES WERE NOTED. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173791 TENDRIL STS No Match NVN ABBOTT MEDICAL (CRM-SYLMAR) 2088TC/58 A000150808 05414734502894

    Patients

    Seq Age Sex Outcome Treatment
    1