BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTPILL GI MONITORING SYSTEM

    MDR report key: 2822298 · Received May 2, 2012

    Report

    Report Number
    1320877-2012-00001
    Event Type
    Injury
    Date Received
    May 2, 2012
    Date of Event
    May 10, 2011
    Report Date
    May 1, 2012
    Manufacturer
    THE SMARTPILL CORPORATION
    Product Code
    NYV
    PMA / PMN Number
    K092342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMART PILL SALES PERSON BECAME AWARE OF ADVERSE EVENT WHILE VISITING CUSTOMER SITE: (B)(6).

    Description of Event or Problem · 1

    PT SEARCHED FOR MOTILITY ON THE INTERNET AND FOUND THAT LANCASTER GASTROENTEROLOGY PERFORMS THE SMARTPILL TEST. BEFORE ADMINISTERING THE SMARTPILL, THE PHYSICIAN REPEATED A CT SCAN BECAUSE THE PT¿S SYMPTOMS WERE SUGGESTIVE OF AN OBSTRUCTION RATHER THAN A MOTILITY DISORDER. THE TEST CAME BACK NEGATIVE AGAIN. THE DOCTOR ADMINISTERED THE SMART PILL AND IT BECAME STUCK IN THE SMALL BOWEL. WHEN THE SMARTPILL FAILED TO PASS IN 3 WEEKS (BEING TRACKED WITH X-RAYS) A BOWEL PREP WAS ADMINISTERED THAT SUCCESSFULLY PROPELLED IT TO PASS. NO ADDITIONAL SYMPTOMS WERE EXPERIENCED WHILE THE SMARTPILL WAS STUCK. AFTER PASSAGE A CT WITH ENTEROGRAPHY (WHICH LOOKS FOR SMALL BOWEL LOOPS) WAS ADMINISTERED AND CAME BACK NEGATIVE. THEY DID AN OLYMPUS VIDEO CAPSULE WHICH OBSERVED A LESION IN THE DISTAL PROX ILEUM. THIS FINDING PROMPTED AN EXPLORATORY LAPORATOMY WHICH RESULTED IN FINDING A CARCINOMA OF THE SMALL BOWEL (A VERY RARE SMALL BOWEL CANCER). PHYSICIAN WAS VERY WARY OF INITIAL RADIOLOGIC RESULTS BECAUSE HE COULDN¿T BELIEVE THE CT SCAN WAS NORMAL, BUT HIS TEST WAS ALSO NORMAL. UNLESS HE HAD PERFORMED A WIRELESS MOTILITY CAPSULE HE WOULD NOT HAVE FOUND THE CANCER.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention