BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTPILL GI MONITORING SYSTEM

    MDR report key: 2380513 · Received September 6, 2011

    Report

    Report Number
    1320877-2011-00002
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    August 5, 2011
    Report Date
    September 2, 2011
    Manufacturer
    THE SMARTPILL CORPORATION
    Product Code
    NYV
    PMA / PMN Number
    K092342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT HAD LAST FOLLOW-UP VISIT ON (B)(6) 2011. AT THAT TIME THERE WAS NO PERMANENT DISABILITY OR IMPAIRMENT. NO ADDITIONAL PATIENT FOLLOW-UP IS PLANNED OR NEEDED.

    Description of Event or Problem · 1

    THE SUBJECT HAD DIFFICULTIES SWALLOWING THE CAPSULE. ADDITIONAL WATER AND APPLE SAUCE WERE GIVEN, BUT THE SUBJECT VOMITED THE CAPSULE. HE AGREED TO MAKE A SECOND EFFORT, BUT EXPERIENCED DISCOMFORT AGAIN AND A FEELING THAT THE CAPSULE WAS LODGED IN HIS THROAT. HE VOMITED A COUPLE OF TIMES AND WAS REFERRED TO THE ER FOR EVALUATION. AN X-RAY IMAGE SHOWED THE CAPSULE IN THE GASTRO-ESOPHAGEAL JUNCTION. SINCE THE CONSERVATIVE TREATMENT OF LIQUID AND BREAD DID NOT RESOLVE THE PROBLEM, A GI CONSOLATION WAS REQUESTED. THE GASTROENTEROLOGIST ORDERED ENDOSCOPIC REMOVAL DUE TO THE SMARTPILL WEDGE IN THE LOWER ESOPHAGEAL SPHINCTER, CAUSING ACUTE OBSTRUCTION. THE SUBJECT WAS TRANSFERRED BACK TO THE UNIT IN THE EVENING, HE WAS ON A LIQUID DIET YESTERDAY AND HE WILL BE ON A PUREE DIET FOR TWO MORE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTPILL GI MONITORING SYSTEM GASTROINTESTINAL MOTILITY CAPSULE NYV THE SMARTPILL CORPORATION PH.P CAPSULE SPC1111601

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention