BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 1855236 · Received October 6, 2010

    Report

    Report Number
    2182208-2010-00688
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    August 27, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT, DUE TO PATIENT ANATOMY, THE PHYSICIAN WAS UNABLE TO COMPLETE THE RIGHT SIDED IMPLANT. WHEN THE RIGHT SIDE WAS ATTEMPTED, THE LINE WOULD KINK AND THE LEAD WOULD NOT BE ABLE TO PROGRESS. THREE LEADS WERE ATTEMPTED, WITHOUT SUCCESS. THE LEADS WERE NOT USED. 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 73 YR Required Intervention