BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO

    MDR report key: 1037247 · Received May 1, 2008

    Report

    Report Number
    2950887-2008-02352
    Event Type
    Injury
    Date Received
    May 1, 2008
    Report Date
    March 28, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    LITERATURE REFERENCE: J LETARD, ET AL. WIRELESS ESOPHAGEAL PH MONITORING: TECHNICAL ASPECT. ACTA ENDOSCOPIA. 2006; 36(2): 163-165. THE ARTICLE DISCUSSES THE RESULTS OF TWENTY-TWO PATIENTS WHO WERE IMPLANTED IN 2005 WITH TELEMETRIC CAPSULE. THE PATIENT EXPERIENCED MODERATE TRANSITORY (<72 HOURS) DYSPHASIA. THE PATIENT HAD BIOPSIES OF THE LOWER THIRD OF THE ESOPHAGUS. RESIDUAL DROPS OF BLOOD COLLECTED IN THE ASPIRATION CHAMBER, WHICH LIMITED ITS FUNCTION. THE SYSTEM WAS REMOVED, THE CAPSULE WASHED WITH STERILE NORMAL SALINE USING SUCTION AND THEN PUT BACK IN PLACE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention