BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPILL

    MDR report key: 6987422 · Received October 30, 2017

    Report

    Report Number
    9710107-2017-05585
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Report Date
    October 30, 2017
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NYV
    PMA / PMN Number
    K092342
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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 CUSTOMER CALLED IN TO REPORT THE PATIENT WAS EXPERIENCING PAIN THE DAY AFTER INGESTING A SMARTPILL CAPSULE. THE PATIENT REPORTED ON A SCALE FROM 1-10 THEIR PAIN WAS AT A 8. THE PAIN RESIDED IN THE UPPER RIGHT ABDOMINAL AND BELOW THE FLANK AREA OF THE LOWER BACK. MEDTRONIC MEDICAL AFFAIRS FOLLOWED-UP WITH THE CUSTOMER AND WAS TOLD THE PATIENT HAD VOMITED TWICE. THE PATIENT WENT TO THE EMERGENCY ROOM AND SPOKE WITH TRIAGE, THE PATIENT SUBSEQUENTLY WENT HOME. THE CUSTOMER FOLLOWED-UP WITH THE PATIENT THE NEXT DAY AND WAS TOLD THE PATIENT WENT BACK TO THE EMERGENCY ROOM AFTER THE INITIALLY VISIT. THEY HAD A TEMPERATURE OF 102. ON (B)(6) 2017 THE PATIENT PASSED THE SMARTPILL CAPSULE AT APPROXIMATELY 9:30AM. THE PATIENT UNDERWENT A CT SCAN WHICH SHOWED A KIDNEY ABSCESS. THE CUSTOMER REPORTED THE PAIN AND FEVER THE PATIENT EXPERIENCED WAS ASSOCIATED WITH THE KIDNEY ABSCESS. THE PATIENT WILL BE REFERRED TO A SPECIALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766829 SMARTPILL GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE NYV GIVEN IMAGING LTD., YOQNEAM 50100100 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| O