BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN SELECT II

    MDR report key: 3992815 · Received August 8, 2014

    Report

    Report Number
    9612164-2014-01050
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K053431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER USED DURING THE IMPLANT PROCEDURE WAS EXPIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471749 ATTAIN SELECT II CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 6248130D02

    Patients

    Seq Age Sex Outcome Treatment
    1