BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1003426 · Received February 21, 2008

    Report

    Report Number
    2032545-2008-00824
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 21, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K022028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE MFR'S REP REPORTED THAT WHILE PLACING A BRAVO PH MONITOR THE CAPSULE WOULD NOT ATTACH TO THE PT'S ESOPHAGUS. NO SERIOUS INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q186799

    Patients

    Seq Age Sex Outcome Treatment
    1