BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 11683156 · Received April 17, 2021

    Report

    Report Number
    2017865-2021-15403
    Event Type
    Injury
    Date Received
    April 17, 2021
    Date of Event
    March 29, 2021
    Report Date
    June 14, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734502870
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-15402. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-15404. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-15405. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND THREE LEADS WERE EXPLANTED. THE PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580573 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/46 P000111443 05414734502870

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR| GALLANT HF| QUARTET