BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SMARTPILL

    MDR report key: 16369440 · Received February 13, 2023

    Report

    Report Number
    9710107-2023-00021
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    December 30, 2022
    Report Date
    February 13, 2023
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NYV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: UNK-SMARTPILL - UNKNOWN SMARTPILL, LOT# UNK. TITLE: EFFECT OF SLEEVE GASTRECTOMY AND ROUX-EN-Y GASTRIC BYPASS ON GASTROINTESTINAL PHYSIOLOGY SOURCE: EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS 183 (2023) 92-101, DOI.ORG/10.1016/J.EJPB.2022.12,018. ACCEPTED DATE 30 DECEMBER 2022. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A PROSPECTIVE STUDY FROM DECEMBER 2019 TO MAY 2021 OF 18 PATIENTS EXPLORED GASTROINTESTINAL MOTILITY, GASTROINTESTINAL PH, AND GASTROINTESTINAL BILE ACID CONCENTRATIONS IN PATIENTS WITH OBESITY, PATIENTS THAT UNDERWENT SLEEVE GASTRECTOMY AND PATIENTS THAT UNDERWENT ROUX-EN-Y GASTRIC BYPASS. THE SMART PILL WAS USED WITH ONE REPORTED CASE OF A NON-SERIOUS CAPSULE RETENTION THAT WAS RESOLVED BY THE INGESTION OF A LAXATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2251275 UNKNOWN SMARTPILL GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE NYV GIVEN IMAGING LTD., YOQNEAM UNKNOWN SMARTPILL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown