BEUDAMED
    FDA Adverse Event Death Summary report: N

    PILLCAM RECORDER, DR3

    MDR report key: 5007395 · Received August 13, 2015

    Report

    Report Number
    9710107-2015-00225
    Event Type
    Death
    Date Received
    August 13, 2015
    Date of Event
    May 13, 2015
    Report Date
    August 13, 2015
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    PMA / PMN Number
    K123864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE REFERENCE NUMBER: (B)(4). THE ACTUAL DEVICE USED IN THE CASE WAS NOT RECEIVED FOR INVESTIGATION, HOWEVER, THE STUDY WAS RETURNED TO MEDTRONIC FOR INVESTIGATION. AFTER REVIEWING THE PARAMETERS, ALL FOUR ANTENNAS WORKED PROPERLY, HOWEVER, THE SHORT VIDEO OCCURED DUE TO THE CAPSULE BATTERY FAILURE AND THE BLACK GAPS IN THE VIDEO OCCURRED DUE TO THE CAPSULE SIGNAL. THE PATIENT DEATH IS UNRELATED TO THE ALLEGED DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    MANUFACTURE REFERENCE NUMBER: (B)(4). THE ACTUAL DEVICE USED IN THE CASE WAS NOT RECEIVED FOR INVESTIGATION, HOWEVER, THE STUDY WAS RETURNED TO MEDTRONIC FOR INVESTIGATION. AFTER REVIEWING THE PARAMETERS, ALL FOUR ANTENNAS WORKED PROPERLY, HOWEVER, THE SHORT VIDEO OCCURED DUE TO THE CAPSULE BATTERY FAILURE AND THE BLACK GAPS IN THE VIDEO OCCURRED DUE TO THE CAPSULE SIGNAL. THE PATIENT DEATH IS UNRELATED TO THE ALLEGED DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    A PT SWALLOWED A PILLCAM CAPSULE WHICH AS STUCK AT THE ENTRANCE OF THE STOMACH. THE CAPSULE WAS PUSHED INTO THE SMALL BOWEL WITH AN ENDOSCOPIC TOOL. IT WAS REPORTED THAT THE PT DIED LATER THAT DAY. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536128 PILLCAM RECORDER, DR3 PILLCAM NEZ GIVEN IMAGING LTD. FGS-0347

    Patients

    Seq Age Sex Outcome Treatment
    1 Death