BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO (X3)

    MDR report key: 1053261 · Received May 28, 2008

    Report

    Report Number
    2950887-2008-02852
    Event Type
    Injury
    Date Received
    May 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    LITERATURE REFERENCE: C PRAKASH, ET AL. ENDOSCOPIC REMOVAL OF THE WIRELESS PH MONITORING CAPSULE IN PATIENTS WITH SEVERE DISCOMFORT. GASTROINTESTINAL ENDOSCOPY. 2006; 64(5): 828-832. ENDOSCOPIC AND PH MONITORING REPORTS WERE REVIEWED FOR 452 PATIENTS WHO UNDERWENT WIRELESS PH MONITORING OVER A 3.5 YEAR PERIOD. ENDOSCOPIC DISLODGEMENT OF THE CAPSULE WAS USED BY NUDGING THE ENDOSCOPIC TIP AND COLD SNARE TECHNIQUES. THREE PATIENTS REQUIRED ENDOSCOPIC CAPSULE DISLODGEMENT BECAUSE OF SEVERE DISCOMFORT, CHEST PAIN AND/OR ODYNOPHAGIA. ENDOSCOPIC REMOVAL PRODUCED MUCOSAL STRIPPING, WHICH REQUIRED HEMOSTATIS IN ONE PATIENT. A COLD SNARE WAS USED SUCCESSFULLY, WITHOUT COMPLICATION, TO SEPARATE THE CAPSULE FROM STRIPPED MUCOSA. CAPSULE REMOVAL RESULTED IN MARKED IMPROVEMENT OF DISCOMFORT. REFERENCE PCR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO (X3) FFT MEDTRONIC NEUROMODULATION 9012B1001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention