BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 22312520 · Received June 23, 2025

    Report

    Report Number
    2017865-2025-89074
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    June 4, 2025
    Report Date
    August 18, 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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE CORRECT DATE OF BIRTH SHOULD HAVE BEEN 'NOV 4, 1941' INSTEAD OF 'NOV 16, 1941'.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE. THE RA LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064385 TENDRIL ST NO MATCH NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1888TC/46 2763385

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention AORTIC PERICARDIAL BIOPROSTHETIC HEART VALVE| ASSURITY PACEMAKER