BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC

    MDR report key: 594032 · Received April 15, 2005

    Report

    Report Number
    MW1035246
    Event Type
    Other
    Date Received
    April 15, 2005
    Date of Event
    April 15, 2005
    Report Date
    April 15, 2005
    Manufacturer
    MEDTRONIC AS
    Product Code
    FFT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CAPSULE DID NOT DEPLOY CORRECTLY. PROCEDURE COMPLETED - PT RE-ENDOSCOPED - TEAR AT SITE OF CAPSULE PLACEMENT - CAPSULE NOT STUCK IN PROXIMAL DUODENUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC BRAVO PH SYSTEM FFT MEDTRONIC AS REF 9012B1011 050110

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other