BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN SELECT II

    MDR report key: 4160941 · Received October 10, 2014

    Report

    Report Number
    9612164-2014-01303
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K123153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE MECHANICAL OPERATION OF THE CATHETER WAS DAMAGED. THE MECHANICAL OPERATION OF THE CATHETER SHAFT WAS BENT. THE MECHANICAL OPERATION OF THE CATHETER PEELING/SLITTING/SPLITTING SHOWED A SPIRAL SLIT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN CUT THE CATHETER. THE CATHETER WAS SEPARATED INTO TWO PARTS AND ONE REMAINED IN THE PATIENT. THE PHYSICIAN EXTRACTED THE REMAIN PIECE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641061 ATTAIN SELECT II CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 6248VI-130 0007165658

    Patients

    Seq Age Sex Outcome Treatment
    1