BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 1861502 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-10052
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. THE FIDELIS DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOISE NOTED ON THE RIGHT VENTRICULAR (RV) P/A CHANNEL AS SEEN ON VENTRICULAR SENSING EPISODES. DUE TO OCCLUSION, THE LEFT VENTRICULAR (LV) BIPOLAR LEAD IS PLUGGED INTO THE RV PACE/SENSE PORT AND THE RV PACE/SENSE LEAD IS PLUGGED INTO THE LV PORT. THIS IS OFF-LABEL SYSTEM SET-UP. THE NOISE OBSERVED COULD NOT BE RECREATED IN THE CLINIC. THE PATIENT IS IN ATRIAL FIBRILLATION. THE LEADS ARE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN 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 PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other D274TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD