BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMT G-JET

    MDR report key: 6945160 · Received October 12, 2017

    Report

    Report Number
    1526012-2017-00008
    Event Type
    Death
    Date Received
    October 12, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 14, 2017
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    UDI-DI
    00842071101381
    PMA / PMN Number
    K123716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION, BUT A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO ANOMALIES WERE FOUND. AMT AGREES WITH THE DOCTOR'S ASSESSMENT THAT THE JEJUNAL PERFORATION WAS CAUSED BY THE PATIENT'S CONDITION AND THE PLACEMENT PROCEDURE, NOT THE DEVICE ITSELF. ALL INFORMATION REASONABLY KNOWN AT THIS TIME HAS BEEN INCLUDED IN THIS REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP REPORT WILL BE PROVIDED. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AMT. WE HAVE ASSIGNED (B)(4) TO THIS REPORT.

    Description of Event or Problem · 1

    BASED ON THE REPORTED INFORMATION FROM THE DOCTOR, THE DOCTOR WAS INVOLVED IN AN OPERATION WITH A (B)(6) PATIENT WITH DOWN SYNDROME. THE PATIENT HAD MANY HEALTH FACTORS AT PLAY, INCLUDING DUODENAL ATRESIA. THE DOCTOR WENT INTO THE PLACEMENT WITH KNOWLEDGE THAT THERE WAS A HIGH RISK DUE TO THE PATIENT'S SITUATION, BUT HAD DECIDED THAT ATTEMPTING THE PROCEDURE WAS STILL THE BEST OPTION. THE PATIENT EXPERIENCED A JEJUNAL PERFORATION FROM THE PLACEMENT PROCEDURE AS CONFIRMED BY THE RADIOLOGIST. THE RADIOLOGIST INVOLVED WITH THE CASE DOES NOT BLAME THE AMT DEVICE AND ONLY PROVIDED THE INFORMATION TO AMT FOR REPORTING PURPOSES. BASED ON THE DOCTOR'S ANALYSIS, HE BELIEVES THAT THE G-JET DEVICE DID NOT CAUSE THE PERFORATION AND IT WAS THE PATIENT'S OTHER FACTORS THAT LEAD TO THE ISSUES EXPERIENCED FROM THE PLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724795 AMT G-JET TRANSGASTRIC-JEJUNAL FEEDING DEVICE KNT APPLIED MEDICAL TECHNOLOGY, INC. GJ-1410-15 170608-107 00842071101381

    Patients

    Seq Age Sex Outcome Treatment
    1 6 WK Death