BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOMAPHYX PLUS

    MDR report key: 1329017 · Received February 27, 2009

    Report

    Report Number
    3005473391-2009-00001
    Event Type
    Injury
    Date Received
    February 27, 2009
    Date of Event
    January 28, 2009
    Report Date
    January 28, 2009
    Manufacturer
    REDMOND
    Product Code
    MFJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN ASKED WHAT THE ROOT CAUSE OF THE BRADYCARDIA WAS, THE SURGEON RESPONDED THAT IT WAS UNDOUBTEDLY A PINCHED VAGUS NERVE. HE WAS ASKED WHAT INFORMATION HE MIGHT PASS ON TO THE COMPANY OR OTHER CUSTOMERS AS PREVENTIVE ACTION, HE RESPONDED THAT THE ANESTHESIOLOGIST SHOULD HAVE PUSHED THE ATROPINE THE FIRST TIME THE HEART SLOWED DOWN AND IT WOULD HAVE CORRECTED THE SITUATION IMMEDIATELY. THE DOCTOR STATED HE WILL PROBABLY RESCHEDULE THIS PATIENT FOR ANOTHER PROCEDURE, AND WILL INITIATE THE ATROPINE IMMEDIATELY TO ENABLE HIM TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    THE CUSTOMER NOTIFIED THE COMPANY AND REPORTED THAT DURING A NORMAL PROCEDURE, WHEN THE DEVICE SUCTION WAS APPLIED TO A SECTION OF TISSUE IN THE GI TRACT AS PART OF THE SEQUENCE TO PLICATE TISSUE, THE PATIENT'S HEART RATE WOULD DECREASE TO A BRADYCARDIC RATE. THE HEART RATE WOULD RESUME NORMAL RHYTHM WHEN THE SUCTION WAS REMOVED AFTER THE FASTENER WAS DEPLOYED IN PLICATING THE TISSUE. THIS OCCURRED THROUGH THREE FASTENER DEPLOYMENTS. ON THE FOURTH PLICATION THE PATIENT WENT INTO ASYSTOLE. THE ANESTHESIOLOGIST PUSHED ATROPINE AND THE PATIENT RESPONDED. THE PROCEDURE WAS ABORTED AT THAT TIME. THERE WAS NOT ALLEGATION OF PRODUCT MALFUNCTION. THE REPORTED ROOT CAUSE OFFERED BY THE PHYSICIAN WAS A PINCHED VAGUS NERVE, WHEN THE TISSUE WAS SUCTIONED. THE PATIENT WAS KEPT IN THE HOSPITAL FOR A FEW DAYS FOR OBSERVATION AND WAS RELEASED WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOMAPHYX PLUS MFJ REDMOND 1.2 NOR REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R