BEUDAMED
    FDA Adverse Event Death Summary report: N

    PILLCAM SB2

    MDR report key: 1397173 · Received January 8, 2009

    Report

    Report Number
    9710107-2009-00002
    Event Type
    Death
    Date Received
    January 8, 2009
    Date of Event
    January 23, 2009
    Report Date
    February 5, 2009
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    PMA / PMN Number
    K070475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAPSULE ENDOSCOPY VIDEO WAS REVIEWED BY THE TREATING PHYSICIAN, AND NO ABNORMALITY WAS FOUND. NO LESIONS OR BLOOD WAS FOUND. THE GASTROINTESTINAL MUCOSA APPEARED NORMAL. IT REVEALED THAT THE ESOPHAGEAL IMAGES WERE NORMAL AND THE CAPSULE REACHED THE STOMACH WITHIN 30 SECONDS. THE STOMACH APPEARED NORMAL AS WELL. THE SMALL BOWEL WAS NORMAL AND THERE WAS NO EVIDENCE OF ANY BLEEDING IN THE STOMACH OR SMALL BOWEL. THE CAPSULE REACHED THE CECUM 5 HOURS AND 20 MINUTES AFTER INGESTION, AND WAS IN THE COLON FOR ABOUT 2 HOURS BEFORE THE STUDY WAS STOPPED BY REMOVAL OF THE EQUIPMENT. THE PHYSICIAN BELIEVES THAT THE REASON FOR THE PATIENT'S DEATH WAS A MYOCARDIAL INFARCT, AND THAT HIS DEATH WAS UNRELATED TO THE CAPSULE ENDOSCOPY PROCEDURE. THE CORONER DECIDED THAT AN AUTOPSY WAS NOT NECESSARY. THE CAUSE OF DEATH WAS DETERMINED TO BE CARDIAC ARREST RELATED TO HIGH OUTPUT CARDIAC FAILURE DUE TO SEVERE ANEMIA. THE TREATING PHYSICIAN DOES NOT BELIEVE THERE WAS ANY RELATIONSHIP BETWEEN THE CAPSULE ENDOSCOPY AND HIS CARDIAC ARREST. GIVEN IMAGING HAS REQUESTED A COPY OF THE CAPSULE ENDOSCOPY VIDEO FOR INTERNAL EVALUATION. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    A MALE UNDERWENT CAPSULE ENDOSCOPY WITH THE PILLCAM SB2 CAPSULE IN 2009. THE PATIENT SWALLOWED THE CAPSULE WITHOUT ANY DIFFICULTY AND SEEMED WELL. THE PATIENT WAS FOUND TO BE UNRESPONSIVE AT APPROXIMATELY 3PM, WAS BROUGHT TO THE EMERGENCY ROOM WHERE RESUSCITATION WAS UNSUCCESSFUL AND HE EXPIRED. THE CAUSE OF DEATH WAS DETERMINED TO BE CARDIAC ARREST DUE TO SEVERE ANEMIA AND HIGH OUTPUT CARDIAC FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLCAM SB2 PILLCAM SB2 NEZ GIVEN IMAGING LTD. SB2 6762S2S

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death