BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1097665 · Received July 25, 2008

    Report

    Report Number
    2032545-2008-04250
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    August 6, 2002
    Report Date
    October 25, 2006
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) WHICH COVERS A TWO YR TIME PERIOD FROM JUNE 1, 2005 TO MAY 30, 2007 FOR PREVIOUSLY UNREPORTED MEDICAL DEVICE REPORTS FOR MEDTRONIC GASTROLOGICAL AND UROLOGICAL (MGU) PROD COMPLAINT REPORTS. THIS EXEMPTION WAS GRANTED TO SATISFY MEDRONIC'S MDR OBLIGATIONS FOR ANY PREVIOUSLY UNREPORTED SERIOUS INJURY AND MALFUNCTION EVENTS FOUND DURING THIS REVIEW. THIS MEDWATCH REPORT REPRESENTS 1,947 UNREPORTED MALFUNCTION EVENTS FOR MODEL 9012B1001; PROD CODE FFT). THIS TOTAL INCLUDES THE EVENTS DESCRIBED IN THIS REPORT. FAILURE TO DETACH EVENTS ARE INCLUDED IN THE BRAVO PH CAPSULE AND DELIVERY SYS 9012B1011 (5-PACK) AND 9012B1001 (SINGLE-PACK) FIELD ACTION - FAILURE TO DETACH, PHYSICIAN COMMUNICATION (03-DECEMBER-2007).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE BRAVO CAPSULE WAS PLACED IN THE PT, IT DID NOT ADHERE TO THE ESOPHAGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 53681

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK