BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2781643 · Received October 10, 2012

    Report

    Report Number
    2182208-2012-03164
    Event Type
    Injury
    Date Received
    October 10, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD IS BEING USED AS THE PACE/SENSE CIRCUIT FOR THE RIGHT VENTRICLE (RV) AND T-WAVE OVERSENSING WAS OBSERVED. SENSITIVITY PARAMETERS WERE CHANGED AND IT WAS NOTED THAT THE PATIENT "FEELS GREAT". IT WAS LATER REPORTED THE LV LEAD CONTINUES TO HAVE T-WAVE OVERSENSING WITH SENSING INTEGRITY COUNTS (SIC) OF GREATER THAN 5000. REPROGRAMMED FROM DDDR TO DDIR TO AVOID INAPPROPRIATE RESPONSE TO THE SENSING CAUSING THE SIC INCREASE. IT WAS LATER REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM AFTER HEARING THE LEAD INTEGRITY ALERT DUE TO THE LV LEAD HAVING INTERMITTENT T-WAVE OVERSENSING. ADDITIONALLY, THE ATRIAL LEAD SHOWS POSSIBLE P-WAVE OVERSENSING. THE LV AND ATRIAL LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB