BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 23187140 · Received September 30, 2025

    Report

    Report Number
    2017865-2025-1001581
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    September 15, 2025
    Report Date
    October 8, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE REPORTABLE AWARE DATE IN REPORT [2017865-2025-1001581] SUBMITTED ON 30 SEP 2025 STATED AS 16 SEP 2025 IS CORRECTED AND UPDATED AS 15 SEP 2025.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR-FIELD R-WAVE OVERSENSING AND INTERMITTENT CAPTURE DUE TO DISLODGEMENT, CONFIRMED VIA CHEST X-RAY IMAGING. A PREVIOUS DISLODGEMENT OF THE RA LEAD HAD ALSO BEEN NOTED AND CONFIRMED VIA X-RAY IMAGING. AS A RESOLUTION, THE RA LEAD WAS INITIALLY REPOSITIONED ON (B)(6) 2025. HOWEVER, DUE TO A SECOND DISLODGEMENT, IT WAS EXPLANTED AND REPLACED ON (B)(6) 2025. THE PATIENT'S CONDITION REMAINED STABLE THROUGHOUT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE RIGHT-ATRIAL (RA) LEAD EXHIBITED A DECREASE IN P-WAVE AMPLITUDE AND HIGH CAPTURE THRESHOLDS AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674040 TENDRIL STS NO MATCH NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/52 P000237287

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention DURATA TACHY| GALLANT HF| QUARTET