BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 16762008 · Received April 18, 2023

    Report

    Report Number
    2017865-2023-17826
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    April 10, 2023
    Report Date
    April 18, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734502870
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RELATED MANUFACTURING REFERENCE NUMBER: 2017865-2023-17825. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD HAD HIGH CAPTURE THRESHOLDS AND THE RIGHT VENTRICULAR (RV) WAS OVER-SENSING NOISE. THE PATIENT WAS ASYMPTOMATIC. BOTH THE RA AND RV LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492115 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/46 3703769 05414734502870

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention ASSURITY MRI| ISOFLEX OPTIM LEAD