BEUDAMED
    FDA Adverse Event Death Summary report: N

    PILLCAM

    MDR report key: 6379771 · Received March 6, 2017

    Report

    Report Number
    9710107-2017-05051
    Event Type
    Death
    Date Received
    March 6, 2017
    Date of Event
    February 7, 2017
    Report Date
    April 16, 2018
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NEZ
    PMA / PMN Number
    K123864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION: DEVICE EVALUATION THE SD CARD FROM THE RECORDER WAS RECEIVED FOR INVESTIGATION. THE VISUAL INSPECTION FOUND NO DEFECTS. THERE WAS NO RAW DATA FOUND ON THE CARD. IT IS LIKELY THAT THE DATA WAS DELETED WHEN TRYING TO PERFORM A NEW CHECK-IN. 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 HAD A PRE-PROCEDURE DIAGNOSIS OF ANEMIA AND HAD NO DIFFICULTIES SWALLOWING THE CAPSULE. THE PATIENT WAS INSTRUCTED TO RETURN TO THE OFFICE IN THE EVENING. THE PATIENT DID NOT RETURN AND THE POLICE WERE CALLED TO CHECK ON THE PATIENT. WHEN THE POLICE ARRIVED, THEY WERE TOLD THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER). THE ADMISSION ER NOTE STATED THAT THE PATIENT WAS DIZZY, HAD A SEVERE HEADACHE, AND FELL AT HOME. HE WAS ADMITTED TO THE HOSPITAL AND TRANSFERRED TO A SUBSEQUENT HOSPITAL THE NEXT DAY. A CRANIOTOMY WAS PERFORMED FOR ACUTE ISCHEMIC STROKE. MEDTRONIC WAS LATER NOTIFIED THAT THE PATIENT HAD EXPIRED AT APPROXIMATELY 2-3PM. THE REPORTING PERSON DID NOT BELIEVE THE PROCEDURE WAS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164951 PILLCAM SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ GIVEN IMAGING LTD., YOQNEAM FGS-0347

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| H