BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN LDS LEFT-HEART DELIVERY SYSTEM

    MDR report key: 3864801 · Received June 10, 2014

    Report

    Report Number
    9612164-2014-00618
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K021587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. 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 LV (LEFT VENTRICULAR) LEAD DISLODGED WHILE SLITTING. THE PHYSICIAN USED A SECOND CATHETER TO IMPLANT THE SAME LEAD SUCCESSFULLY. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337848 ATTAIN LDS LEFT-HEART DELIVERY SYSTEM CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 6216A003 0006885406

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR UNK LEAD