BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO

    MDR report key: 1063242 · Received June 19, 2008

    Report

    Report Number
    2182207-2008-03360
    Event Type
    Injury
    Date Received
    June 19, 2008
    Report Date
    March 25, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: FAJARDO, RN. ESOPHAGEAL PERFORATION AFTER PLACEMENT OF A WIRELESS BRAVO PH PROBE. GASTOINTEST, ENDOSE. 63(1), 181-185 (2006). THE ARTICLE DESCRIBE TWO ESOPHAGEAL PERFORATION EVENTS. THE SECOND EVENT INVOLVED A PT SEEN AT THE AUTHORS INSTITUTION BY ONE OF THE CO-AUTHORS (G. RICHARD LOCKE). THE CO-AUTHOR REPORTED A PT HAD EXPERIENCED AN ESOPHAGEAL PERFORATION AFTER THE STUDY WAS PERFORMED AT ANOTHER INSTITUTION (UNK). NO ADD'L PT OUTCOME AND EVENT DETAILS WERE SPECIFIED IN THE ARTICLE. FOLLOW-UP HAS BEEN INITIATED TO ESTABLISH MORE SPECIFIC EVENT DETAILS AND SHOULD ADD'L INFO BE RECEIVED, IT WILL BE PROVIDED IN A FOLLOW-UP REPORT. THE CASE STUDY DESCRIBED IN THE ARTICLE INVOLVING A PT HAS BEEN REPORTED UNDER MDR 2182207200801397.

    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 Other