BEUDAMED
    FDA Adverse Event Death Summary report: N

    PILLCAM

    MDR report key: 21116421 · Received January 9, 2025

    Report

    Report Number
    9710107-2025-00007
    Event Type
    Death
    Date Received
    January 9, 2025
    Report Date
    January 9, 2025
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NEZ
    PMA / PMN Number
    K211684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY AFTER IT WAS REPORTED THAT THE CAPSULE WAS RETAINED. THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366639 PILLCAM SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C NEZ GIVEN IMAGING LTD., YOQNEAM FGS-0501 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death