BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 2223019 · Received August 19, 2011

    Report

    Report Number
    MW5021836
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 19, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ERROR MESSAGE 50,0032 APPEARED, LEAK IN OUTER BALLOON INDICATING COMPROMISE TO OUTER BALLOON. NO ADVERSE EVENT TO THE PT. CATHETER REMOVED AND NEW ONE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ARTIC FRONT CATH OAE MEDTRONIC CRYOCATH LP 2AF282 76646

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR