BEUDAMED
    FDA Adverse Event Death Summary report: N

    PILLCAM

    MDR report key: 12229112 · Received July 27, 2021

    Report

    Report Number
    9710107-2021-00338
    Event Type
    Death
    Date Received
    July 27, 2021
    Report Date
    July 26, 2021
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NEZ
    UDI-DI
    07290101362951
    PMA / PMN Number
    K123864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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, THE PATIENT WAS HOSPITALIZED FOR DIGESTIVE BLEEDING OF OBSCURE ORIGIN WHICH WAS IN THE MIDDLE PART OF THE DIGESTIVE SYSTEM, SMALL INTESTINE. THE PATIENT SWALLOWED THE CAPSULE ON (B)(6) 2021. THE PATIENT HAD NO SWALLOWING DISORDERS AND WAS ABLE TO SWALLOW THE CAPSULE WITHOUT DIFFICULTY. 5 DAYS AFTER THE STUDY WAS CARRIED OUT, THE PATIENT DIED WITH THE CAPSULE IN THE BODY. THE STUDY YIELDED NO RESULTS. THE PATIENT HAD NO DELAYED GASTRIC EMPTYING ISSUES AND NO INTERVENTION WAS DONE TO REMOVE THE CAPSULE. WHEN VIEWING THE IMAGES, THE DOCTOR WAS ABLE TO VERIFY THAT THE CAPSULE WAS MORE THAN 8 HOURS IN THE ESOPHAGUS WHEN THE NORMAL THING WAS THAT IT PASSES IN 15 SECONDS. IT STAYED 3 HOURS IN THE STOMACH WHERE THE CAPSULE WAS DEACTIVATED DUE TO HAVING EXHAUSTED THE 11 HOURS OF BATTERY. THE STUDY WAS INCOMPLETE BECAUSE THE CAPSULE DID NOT REACH THE BLIND COLON DUE TO THE SLOWING DOWN OF THE PATIENT'S TRANSIT TIMES. THE PRODUCT SPECIALIST WAS ABLE TO SEE THE VIDEO AND OBSERVED THE SAME THING THAT THE DOCTOR INDICATED R EGARDING THE TOTALLY ALTERED TRANSIT TIMES. THE CAPSULE PROGRESSED THROUGH THE MUCOSA OF THE DIGESTIVE SYSTEM, PROPELLED BY THE PERISTALTIC MOVEMENTS OF THE PATIENT, AND DID NOT HAVE IN ITSELF A MECHANISM THAT MAKES IT MOVE. THERE WAS ABNORMAL GASTROINTESTINAL MOT ILITY FOUND ON THE VIDEO BUT AN X-RAY WAS NOT PERFORMED AND MAY NOT HAVE BEEN RELEVANT. BASED ON INFORMATION OBTAINED THUS FAR, IT WAS UNCLEAR IF THE DEVICE CONTRIBUTED TO THE PATIENT'S DEATH. ACCORDING TO THE DOCTOR, THE DEATH OCCURRED DUE TO MULTIPLE ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126414 PILLCAM SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C NEZ GIVEN IMAGING LTD., YOQNEAM FGS-0347 07290101362951

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death