BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 3020900 · Received March 19, 2013

    Report

    Report Number
    MW5029467
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 19, 2013
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RELEASE WHEEL FOR THE SUPRARENAL CAP FAILED TO DEPLOY THE RELEASING STENT. DEVICE HAD TO BE MANUALLY DEPLOYED. NO HARM TO PT OTHER THAN INCREASED FLUORO AND ANESTHESIA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113191 MEDTRONIC ENDURANT 2 MIH ETBF2516C166E

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR