BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLICATOR

    MDR report key: 801450 · Received January 3, 2007

    Report

    Report Number
    1226693-2006-00004
    Event Type
    Injury
    Date Received
    January 3, 2007
    Date of Event
    February 20, 2006
    Report Date
    December 29, 2006
    Manufacturer
    NDO SURGICAL, INC.
    Product Code
    KOG
    PMA / PMN Number
    k032820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NEITHER THE INSTRUMENT NOR THE IMPLANT WERE AVAILABLE FOR INSPECTION. THERE WAS NO REPORTED PRODUCT MALFUNCTION ASSOCIATED WITH THIS EVENT. CONCLUSIONS: THERE IS NO APPARENT PRODUCT MALFUNCTION IN THIS INSTANCE. IT IS ANTICIPATED THAT PLICATOR THERAPY AND ITS ASSOCIATED TRANSMURAL PENETRATION OF THE GASTRIC CARDIA WHILE THE STOMACH IS INSUFFLATED WITH AIR WILL RESULT IN AIR MIGRATING FROM THE STOMACH TO BELOW THE DIAPHRAGM. ANTIBIOTIC THERAPY WAS GIVEN AS A PRECAUTION DUE TO THE SLIGHTLY ELEVATED WBC COUNT. THIS PT'S, POST-PLICATOR TREATMENT DISCOMFORT WAS LIKELY RELATED TO THE SUB-DIAPHRAGMATIC AIR AND THE RESOLUTION OF THE DISCOMFORT WITHIN SEVERAL DAYS OF PLICATOR TREATMENT IS CONSISTENT WITH PREVIOUS REPORTS AND LIKELY ASSOCIATED WITH THE DIMINUTION OF AIR BELOW THE DIAPHRAGM. WE ARE INTERPRETING THIS CASE CONSERVATIVELY AND VIEWING THE ELEVATED WBC COUNT AS A "SEROUS INJURY" THAT RESPONDED TO ANTIBIOTIC THERAPY. ACCORDINGLY, AN MDR FILING IS REQUIRED. WE WILL CONTINUE TO MONITOR THE FREQUENCY OF SUCH REPORTS GOING FORWARD.

    Description of Event or Problem · 1

    5 DAYS SUBSEQUENT TO RECEIVING PLICATOR THERAPY FOR GERD, PT EVIDENCED ELEVATED TEMPERATURE (101DEGREES F) AND WBC COUNT (11). PT WAS TREATED WITH ANTIBIOTICS AND RECOVERED UNEVENTFULLY. REFLUX WAS "MUCH IMPROVED". BACKGROUND: IN 2006, A MALE PT REC'D PLICATOR THERAPY. THE TREATMENT PROCEDURE WAS PERFORMED BY DR AND WAS ROUTINE. THE FOLLOWING DAY, THE PT "WAS FINE". FOUR DAYS LATER, THE PT COMPLAINED OF EPIGASTRIA PAIN WHICH PERSISTED FOR 4 DAYS AND THEN RESOLVED. THE PT UNDERWENT A CHEST X-RAY THAT REVEALED "SIGNIFICANT SUB-DIAPHRAGMATIC FREE AIR" AND A GASTROGRAPHIN STUDY THAT WAS NEGATIVE FOR LEAKAGE. THE PT EVIDENCED A TEMPERATURE OF 101 F AND A WBC OF 11. THE PT WAS TREATED WITH CIFLOXACIN AND THEN CIPRO AND FLAGYL. THE PT RECOVERED FROM THE EVENT AND REPORTED THAT HIS REFLUX WAS MUCH IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLICATOR ENDOSCOPE / ACCESSORY KOG NDO SURGICAL, INC. 160-1130 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention SEE ATTACHED