BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN COMMAND

    MDR report key: 2131734 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00919
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    March 10, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE PHYSICIAN WAS UNABLE TO IMPLANT THE LEFT VENTRICULAR LEAD DUE TO NOT BEING ABLE TO ACCESS THE CORONARY SINUS (CS) WITH THE CATHETER. THERE WERE TWO ATTEMPTS AT POSITIONING. IN THE FIRST ATTEMPT THE CS WAS ACCESSED, BUT THE CATHETER FELL OUT. THE SECOND ATTEMPT WOULD NOT GO IN. THE CATHETER WAS NOT USED AND THE LEAD WAS NOT OPENED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN COMMAND LEFT HEART DELIVERY SYSTEM DQY MEDTRONIC, INC. 6250MPR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other