BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN SELECT II

    MDR report key: 4161593 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02656
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 7, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQY
    PMA / PMN Number
    K053431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE LEAD DISLODGED DURING SLITTING OF THE DELIVERY CATHETER SHEATH. THE CATHETER WAS REMOVED AND REPLACED WITH A NEW DEVICE TO COMPLETE THE IMPLANTATION SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640944 ATTAIN SELECT II CATHETER, PERCUTANEOUS DQY MEDTRONIC, INC. 624890D02 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1