BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLICATOR PROCEDURE FOR ACID REFLUX

    MDR report key: 716841 · Received April 27, 2006

    Report

    Report Number
    MW1038912
    Event Type
    Injury
    Date Received
    April 27, 2006
    Date of Event
    March 30, 2006
    Report Date
    April 27, 2006
    Manufacturer
    NDO SURGICAL
    Product Code
    KOG
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES IMMEDIATELY AFTERWARDS HE EXPERIENCED "EXCRUCIATING" LEFT SHOULDER PAIN. THE PAIN WAS SO SEVERE THAT HE COULDN'T SLEEP AT NIGHT, REQUIRED PAIN MEDICATION AND HE FREQUENTED THE EMERGENCY ROOM ON SEVERAL OCCASIONS SEEKING PAIN RELIEF. HE STATES THAT THE PROCEDURE WAS "INEFFECTIVE" AND HE BELIEVES THAT OTHERS ARE EXPERIENCING THE SAME PROBLEM. IN FACT, THERE'S A GERD WEB SITE WHERE YOU CAN REPORT INFO ON GERD AND WHEN HE LAST CHECKED, THERE WERE 4-5 POSTINGS EXPERIENCING THE SAME PROBLEMS AS HIS. HIS SYMPTOMS INCLUDED VOMITING ALL DAY WITH ACID ON AND OFF, SEVERE CHEST TIGHTNESS AND BREATHING DIFFICULTIES. HE WAS "TOTALLY HOME BOUND," BECAUSE OF THE SYMPTOMS. THEY'VE FINALLY ABATED, BUT CAN FLARE UP FROM TIME TO TIME. REPORTER STATES THAT THE COMPANY BUILDS THE PROCEDURE UP AS IF ITS A "SOLTUION" TO GERD. HE'S INVOLVED IN A STUDY WITH NDO SURGICAL. HE'S BEGGING THEM TO REMOVE THE DEVICE, BUT THEY WOULDN'T DO IT, UNTIL HE WROTE A FORMAL LETTER TO HIS DR REQUESTING THAT IT BE DONE. AND IT WAS REMOVED TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLICATOR PROCEDURE FOR ACID REFLUX ENDOSCOPY KOG NDO SURGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention