BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN

    MDR report key: 1874820 · Received October 19, 2010

    Report

    Report Number
    2182208-2010-00828
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    July 16, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQY
    PMA / PMN Number
    K061480
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE CATHETER WAS SLIT SPIRALLY AND THE PULL WIRE WAS CAUGHT AND BROKEN 21 CM FROM THE HUB. IT APPEARED THAT THE CATHETER HAD BEEN DAMAGED DURING AN IMPLANT PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SLITTER GOT STUCK MIDWAY DOWN THE CATHETER. ANOTHER DELIVERY SYSTEM WAS USED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN LEFT HEART DELIVERY SYSTEM DQY MEDTRONIC, INC. 6227DEF ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R