BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO

    MDR report key: 1036444 · Received May 1, 2008

    Report

    Report Number
    2950887-2008-02327
    Event Type
    Injury
    Date Received
    May 1, 2008
    Report Date
    February 15, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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: AHLAWAT SK, ET AL. "DAY-TO-DAY VARIABILITY IN ACID REFLUX PATTERNS USING THE BRAVO PH MONITORING SYSTEM". J CLIN GASTROENTEROL 2006; 40(1): 20-24. ARTICLE ATTACHED TO MANUFACTURER REPORT: 2950887-2008-02326. THE ARTICLE DISCUSSES NINETY PTS WHO UNDERWENT PH CAPSULE PLACEMENT FROM OCTOBER 2002 TO AUGUST 2003 AT A TERTIARY CARE HOSPITAL FOR PERSISTENT REFLUX SYMPTOMS. ONE PT REPORTED SIGNIFICANT CHEST PAIN FOLLOWING PLACEMENT OF THE CAPSULE. THE PT HAD AN UPPER ENDOSCOPY TO REMOVE THE CAPSULE THE DAY AFTER PLACEMENT OF THE CAPSULE.

    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