BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALLANT HF

    MDR report key: 11683157 · Received April 17, 2021

    Report

    Report Number
    2017865-2021-15402
    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
    NIK
    UDI-DI
    05415067032010
    PMA / PMN Number
    P030054
    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: 2017865-2021-15403. 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
    580574 GALLANT HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CDHFA500Q S000078094 05415067032010

    Patients

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