BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN COMMAND

    MDR report key: 2951844 · Received February 9, 2013

    Report

    Report Number
    9612164-2013-00148
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 6, 2012
    Report Date
    November 25, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K080428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS USED AFTER THE EXPIRATION DATE. THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55733 ATTAIN COMMAND CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 6250S02

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female