BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLICATOR

    MDR report key: 806728 · Received December 30, 2006

    Report

    Report Number
    1226693-2006-00003
    Event Type
    Injury
    Date Received
    December 30, 2006
    Date of Event
    April 27, 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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO APPARENT PRODUCT MALFUNCTION IN THIS INSTANCE. IT IS LIKELY THAT SOME OF THIS PT'S REPORTED SYMPTOMS ARE RELATED TO THIS POTS DIAGNOSIS AND NOT RELATED TO HIS PLICATOR TREATMENT. IN MOST PREVIOUS CASES, POST-PLICATOR TREATMENT DISCOMFORT RESOLVED SPONTANEOUSLY WITHIN SEVERAL DAYS OR SEVERAL WEEKS OF THERAPY DELIVERY. IN THIS CASE, THE PT REQUESTED REVERSAL OF THE PROCEDURE IN A RELATIVELY BRIEF TIMEFRAME OF ITS DELIVERY AND IT IS LIKELY, BASED ON PREVIOUS EXPERIENCE, THAT HIS SYMPTOMS WOULD HAVE RESOLVED SPONTANEOUSLY GIVEN MORE TIME. THERE HAVE BEEN INFREQUENT PREVIOUS REPORTS OF SUSTAINED, SIGNIFICANT, POST PROCEDURE DISCOMFORT IN PTS WHO HAVE REC'D PLICATOR GERD THERAPY. IN ALL SUCH CASES, REVERSAL OF THE PROCEDURE HAS RESULTED IN ELIMINATION OF REPORTED PAIN AND DISCOMFORT (ALTHOUGH GERD SYMPTOMS HAVE RETURNED TO THEIR PRE-TREATMENT STATE). WE WILL CONTINUE TO MONITOR THE FREQUENCY OF SUCH REPORTS GOING FORWARD.

    Description of Event or Problem · 1

    MALE PT REC'D PLICATOR THERAPY FOR GERD IN 2006. SEVEN DAYS LATER, PT REPORTED LEFT SHOULDER EPIGASTRIC AND LOWER ABDOMINAL PAIN. PT FILED MAUDE REPORT (#MW1038912) IN 2006 AND REPORTED THAT "...SYMTPOMS HAD FINALLY ABATED...." HIS PLICATOR PROCEDURE WAS SUCCESSFULLY REVERSED VIA ENDOSCOPIC INTERVENTION 22 DAYS LATER.

    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 * Required Intervention