BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEOTRACT UROLIFT SYSTEM UL400

    MDR report key: 9594067 · Received January 15, 2020

    Report

    Report Number
    3005791775-2020-00006
    Event Type
    Death
    Date Received
    January 15, 2020
    Date of Event
    December 17, 2019
    Report Date
    January 15, 2020
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020001
    PMA / PMN Number
    K173087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019, NEOTRACT BECAME AWARE OF A (B)(6) YEAR-OLD PATIENT, WITH A PAST MEDICAL HISTORY OF CARDIAC ARTERY DISEASE (CAD) AND OTHER CARDIAC EVENTS, WHO UNDERWENT A SUCCESSFULLY COMPLETED PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2019. POST PROCEDURE, THE PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED SOMNOLENCE AND CONFUSION, AND HE BECAME UNCONSCIOUS. THE PATIENT UNDERWENT CPR AND RECEIVED DEFIBRILLATION WITH NO RESPONSE. THE PHYSICIAN REPORTED THAT HE WAS THEN TRANSFERRED TO A HOSPITAL WHERE HE EXPIRED LATER THAT DAY. THE PHYSICIAN STATED HE DOES NOT BELIEVE THE PUL PROCEDURE CAUSED THE PATIENT¿S DEATH. THERE IS A LACK OF MEDICAL INFORMATION TO CONCLUSIVELY LINK THE PATIENT¿S DEATH WITH EITHER THE DEVICE OR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54383 NEOTRACT UROLIFT SYSTEM UL400 UROLIFT SYSTEM PEW NEOTRACT, INC. UROLIFT SYSTEM UNKNOWN 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death