BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAR

    MDR report key: 9962563 · Received April 15, 2020

    Report

    Report Number
    3004904811-2020-00008
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    May 12, 2019
    Report Date
    October 26, 2020
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    GEI
    UDI-DI
    10884521211599
    PMA / PMN Number
    K142364
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    TITLE SELF-SIZING RADIOFREQUENCY ABLATION BALLOON FOR ERADICATION OF BARRETT¿S ESOPHAGUS: RESULTS OF AN INTERNATIONAL MULTICENTER RANDOMIZED TRIAL COMPARING 3 DIFFERENT TREATMENT REGIMENS SOURCE AMERICAN SOCIETY FOR GASTROINTESTINAL ENDOSCOPY, 2019(1-9) DATE OF PUBLICATION: 12 MAY 2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN SEPTEMBER 2015 AND OCTOBER 2017, IN THE SIMPLE-SINGLE ARM, 1 PATIENT WAS ADMITTED FOR 1 NIGHT DUE TO RETROSTERNAL PAIN AND FEVER. NO STENOSIS WAS REPORTED IN THE STANDARD OR SIMPLE-SINGLE ARM. IN THE SIMPLE-DOUBLE ABLATION ARM BETWEEN SEPTEMBER 14, 2015, AND OCTOBER 23, 2017, A TOTAL OF 104 PATIENTS WERE ENROLLED. IN FEBRUARY 2017, INCLUSION OF SIMPLE-DOUBLE ABLATION ARM WAS STOPPED PREMATURELY BECAUSE OF AN UNEXPECTED HIGH RISK OF STENOSIS. 6 PATIENTS DEVELOPED A STENOSIS. OF THESE 6 PATIENTS, 4 DEVELOPED A SEVERE STENOSIS REQUIRING 12 DILATIONS AND 2 INCISION THERAPIES, 8 DILATIONS, 7 DILATIONS, 4 DILATIONS AND 1 INCISION THERAPY. ONE PATIENT HAD A MODERATE STENOSIS REQUIRING 4 DILATIONS, AND ONE STENOSIS WAS GRADED AS MILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425151 DAR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN LP BARRX 64082 10884521211599

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O| R