BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO

    MDR report key: 1075604 · Received July 14, 2008

    Report

    Report Number
    2182207-2008-04012
    Event Type
    Injury
    Date Received
    July 14, 2008
    Report Date
    June 16, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ESOPHAGEAL PH MONITOR. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: GUNNARSDOTTIR A, STENSTROM P, ARNBJORNSSON E. WIRELESS ESOPHAGEAL PH MONITORING IN CHILDREN. J LAPAROENDOSC ADV SURG TECH A. 2008; 18(3):443-447. THE AIM OF THIS STUDY WAS TO REPORT ON OUR EXPERIENCE WITH THE WIRELESS SYSTEM IN CHILDREN. A SECONDARY AIM WAS TO SEE IF THERE WAS ANY CUT-OFF LEVEL FOR ESOPHAGEAL ACID EXPOSURE CAUSING ESOPHAGITIS AS VERIFIED BY PATHOLOGIC EXAMINATION. A TOTAL OF 62 WIRELESS 24-HOUR PH MEASUREMENTS WITH THE BRAVO CAPSULE WERE CARRIED OUT OVER A PERIOD OF 2 YEARS IN 58 CHILDREN WITH SYMPTOMS OF GERD. REPORTABLE EVENT: IN 2 CHILDREN, WE HAD TECHNICAL PROBLEMS WITH FASTENING THE CAPSULE, REQUIRING 3 CAPSULES IN 1 PT. TECHNICAL DIFFICULTIES, WHICH ALL OCCURRED IN THE LEARNING PERIOD OF APPLYING THE SUCTION DEVICE, MIGHT BE EXPECTED WITH NEW TECHNOLOGY AND INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT MEDTRONIC NEUROMODULATION 9012B1001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RECEIVER MODEL 9043K0102 N=1