BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PILLCAM

    MDR report key: 9407118 · Received December 3, 2019

    Report

    Report Number
    9710107-2019-00589
    Event Type
    Death
    Date Received
    December 3, 2019
    Date of Event
    May 8, 2018
    Report Date
    December 3, 2019
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NEZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    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, THE PATIENT WAS DIAGNOSED WITH CROHN'S DISEASE AFFECTING THE SMALL AND LARGE BOWEL AND WAS BEING ADMINISTERED OF REMICADE. THE PATIENT PRESENTED FOR A PILLCAM PROCEDURE APPROXIMATELY A YEAR AND HALF AFTER BEING DIAGNOSED WITH CROHN'S DISEASE. THE PATIENT WAS ADMINISTERED A CAPSULE. APPROXIMATELY THREE WEEKS AFTER THE PILLCAM CAPSULE WAS ADMINISTERED, THE PATIENT WAS SEEN IN THE EMERGENCY DEPARTMENT WITH SEVERE ABDOMINAL PAIN. IT WAS DISCOVERED THAT THE CAPSULE HAS LODGED INTO THE PATIENT'S SMALL BOWEL; THE PATIENT¿S BOWEL WAS PERFORATED. THE PATIENT HAD FREE AIR IN THE ABDOMEN, A LARGE AREA OF DEAD SMALL AND LARGE INTESTINE TISSUE, INFECTION, AND ISCHEMIA. THE PATIENT UNDERWENT EMERGENCY SURGERY, WHICH INCLUDED EXPLORATORY LAPAROTOMY VIA A TRANSVERSE RIGHT LOWER-QUADRANT INCISION, ABDOMINAL WASHOUT, ILEOCECECTOMY WITH COMPLETE RIGHT HEMICOLECTOMY, AND A STAPLED SIDE-TO-SIDE FUNCTIONAL END-TO-END ILEOCOLOSTOMY WITH DIVERTING LOOP ILEOSTOMY REQUIRING LARGE SECTIONS OF DEAD BOWEL TISSUE TO BE EXCISED. APPROXIMATELY 19 DAYS LATER, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199803 UNKNOWN PILLCAM SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ GIVEN IMAGING LTD., YOQNEAM UNKNOWN PILLCAM

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death