BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 939378 · Received April 13, 2007

    Report

    Report Number
    2032545-2007-01329
    Event Type
    Malfunction
    Date Received
    April 13, 2007
    Report Date
    March 16, 2007
    Manufacturer
    NA
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. IF FURTHER INFORMATION IS RECEIVED OR THE DEVICE RETURNED, A FOLLOW-UP MEDWATCH REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE HCP REPORTED THAT WHILE PLACING A BRAVO PH MONITOR THE CAPSULE WOULD NOT DEPLOY FROM THE DELIVERY SYSTEM. IT IS UNK WHETHER THE CAPSULE HAD ATTACHED TO THE PT'S ESOPHAGUS. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT FFT NA 9012B1001 Q180026

    Patients

    Seq Age Sex Outcome Treatment
    1 YR