BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 11683154 · Received April 17, 2021

    Report

    Report Number
    2017865-2021-15404
    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
    NVY
    UDI-DI
    05414734503174
    PMA / PMN Number
    P950022
    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: 2017865-2021-15403. 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
    580569 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 7122Q/58 A000100001 05414734503174

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention GALLANT HF| QUARTET| TENDRIL STS