BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SMARTPILL

    MDR report key: 21839954 · Received April 15, 2025

    Report

    Report Number
    9710107-2025-00158
    Event Type
    Injury
    Date Received
    April 15, 2025
    Report Date
    April 15, 2025
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NYV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BRADEN KUO, ALLEN A. LEE, THOMAS ABELL, ASHOK ATTALURI, MICHAEL CLINE, WILLIAM HASLER, VINCENT HO, ANTHONY J. LEMBO, AMIR MASOUD, RICHARD MCCALLUM, BAHARAK MOSHIREE, EAMONN M. M. QUIGLEY, SATISH S. C. RAO, ABIGAIL STOCKER, MAYRA SANCHEZ, IRENE SAROSIEK, BRIAN SURJANHATA, JERRY ZHOU,7 AND WILLIAM D. CHEY; THE ASSESSMENT OF GASTROINTESTINAL TRANSIT BY THE ATMO CAPSULE: A COMPARISON WITH THE SMARTPILL CAPSULE;(HTTP://CREATIVECOMMONS.ORG/LICENSES/BY/4.0/) HTTPS://DOI.ORG/10.1016/J.CGH.2024.12.013. 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

    ACCORDING TO THE LITERATURE, A PROSPECTIVE STUDY COMPARED THE PERFORMANCE OF SMARTPILL AND A COMPETITOR WIRELESS MOTILITY CAPSULE FOR MEASUREMENT OF GASTROINTESTINAL TRANSIT IN PATIENTS WITH CONFIRMED OR SUSPECTED DISORDERED GASTROINTESTINAL TRANSIT FROM 2023 TO 2024. THERE WERE 213 PATIENTS IN THE STUDY AND ALL PATIENTS SWALLOWED BOTH CAPSULES. ADVERSE EVENTS RELATED TO THE SMARTPILL INCLUDED DATA LOSS IN 48 PATIENTS AND RETENTION IN 16 PATIENTS. RETENTION WAS CONFIRMED BY X-RAY IMAGING AND COMPUTED TOMOGRAPHY SCANS. TREATMENT FOR RETENTION OF BOTH SMARTPILL AND THE COMPETITOR CAPSULE INCLUDED RESCUE LAXATIVES AND COLONOSCOPIES. BODY EXIT FOR ALL CAPSULES INGESTED WAS CONFIRMED BY END OF STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116374 UNKNOWN SMARTPILL gastrointestinal motility system, capsule NYV GIVEN IMAGING LTD., YOQNEAM UNKNOWN SMARTPILL

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention