BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1062424 · Received June 6, 2008

    Report

    Report Number
    1062424
    Event Type
    Malfunction
    Date Received
    June 6, 2008
    Date of Event
    April 10, 2008
    Report Date
    June 6, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NEZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN MADE FOUR ATTEMPTS WITH FOUR DIFFERENT CAPSULES AND EACH TIME THE CAPSULE FAILED TO DEPLOY. ON THE FIFTH ATTEMPT A CAPSULE WAS SUCCESSFULLY DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO MONITOR, ESOPHAGEAL PH NEZ MEDTRONIC, INC. * Q220884, Q206394, Q220884

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR