BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 2203020 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01227
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    February 14, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 A PROCEDURE A LEFT VENTRICULAR (LV) LEAD WAS ATTEMPTED TO BE IMPLANTED, BUT AFTER THE LEAD KEPT FALLING INTO THE MAIN CORONARY SINUS (CS) AND NOT KEEPING ITS PLACEMENT, THE ATTEMPT WAS ABANDONED AND THE LEAD WAS REMOVED. THE PATIENT RECEIVED A DUAL-CHAMBER PACEMAKER AFTER THE ATTEMPT, SO A NEW LV LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other (B)(4) IMPLANTABLE PACING LEADS