BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1000522 · Received February 15, 2008

    Report

    Report Number
    2032545-2008-00703
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 14, 2008
    Report Date
    January 15, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    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, 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 ATTACH TO THE PATIENT'S ESOPHAGUS. THE CLINICIAN FELT THAT THE CAPSULE TROCAR DID NOT COMPLETELY ADVANCE. THE CAPSULE FELL OFF OF THE DELIVERY SYSTEM UPON REMOVAL FROM THE PATIENT. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q211970

    Patients

    Seq Age Sex Outcome Treatment
    1