BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO

    MDR report key: 6474903 · Received April 10, 2017

    Report

    Report Number
    9710107-2017-05155
    Event Type
    Injury
    Date Received
    April 10, 2017
    Report Date
    March 27, 2017
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NEZ
    PMA / PMN Number
    K090557
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, A PATIENT INGESTED A PATENCY CAPSULE APPROXIMATELY A WEEK AGO AND THE CAPSULE STILL NOT DISSOLVED. TWO DAY AFTER INGESTING THE CAPSULE, THE PATIENT EXPERIENCED NAUSEA, VOMITING AND PAIN. THE PHYSICIAN STATES THAT THE PATIENT IS EXHIBITING OBSTRUCTIVE SYMPTOMS.. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND HAD A CT SCAN AND A KIDNEY, URETER, AND BLADDER XRAY (KUB) WAS PERFORMED. THIRTY HOURS AFTER INGESTION, THE KUB SHOWED THE CAPSULE REMAINED IN THE SMALL BOWEL OR COLON, AND OVER THE NEXT APPROXIMATELY TWELVE HOURS THE PATIENT DEVELOPED SYMPTOMS CONSISTENT WITH A SMALL BOWEL OBSTRUCTION (SBO). A CT SCAN SHOWED THE CAPSULE IN THE TERMINAL ILEUM. THE PATIENT IS BEING MANAGED FOR SBO AND HAS BEEN UNDERGOING DAILY KUBS AND THE CAPSULE HAS DISSOLVED, WITH ONLY THE RFID TAG STILL VISIBLE. THE PATIENT IS ON CORTICOSTEROIDS TO REDUCE INFLAMMATION ASSOCIATED WITH THE CROHN¿S DISEASE. THE PHYSICIAN ADMINISTERED GOLYTELY AND THE RFID TAG DID PASS. NO OTHER KNOWN ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259193 BRAVO SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ GIVEN IMAGING LTD., YOQNEAM FGS-0109

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R