BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 1864906 · Received October 12, 2010

    Report

    Report Number
    2182208-2010-00783
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 THE LEAD SERIAL NUMBERS ARE DIFFICULT TO READ. THE PHYSICIAN ALSO QUESTIONED WHY THE LEAD LENGTHS AND MARKERS ARE NOT ON OUR LEADS FOR EASY IDENTIFICATION. THE PHYSICIAN COMMENTED THAT NOT HAVING THIS INFORMATION AVAILABLE ON LEADS CAUSES UNNECESSARY DELAYS AND INCREASED RISK OF PLACING LEADS IN WRONG PORT. THE LEADS ARE STILL 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
    1 ASKU IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. LEAD/MEDT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other