BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC INC

    MDR report key: 718010 · Received May 5, 2006

    Report

    Report Number
    MW1039039
    Event Type
    Malfunction
    Date Received
    May 5, 2006
    Date of Event
    April 17, 2006
    Report Date
    May 5, 2006
    Manufacturer
    MEDTRONIC INC
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING BRAVO PH CAPSULE IMPLANTED DURING GI PROCEDURE. BRAVO CAPSULE FAILED TO DEPLOY. NO INJURY TO PT. THIS OCCURRED X2 WITH SAME PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INC BRAVO PH CAPSULE FFT MEDTRONIC INC 9012B1011 13343
    2 MEDTRONIC BRAVO PH CAPSULE FFT * 9012B1011 13343

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR