BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3860208 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05542
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    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. CONCOMITANT PRODUCT: A2DR01 IMPLANTABLE PULSE GENERATOR, (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT, THE ATRIAL LEAD IMPEDANCE WAS WITHIN NORMAL RANGE. A CHECK THE SAME DAY SHOWED THE BIPOLAR LEAD IMPEDANCE WAS LOW. THE LEAD WAS CHECKED IN UNIPOLAR AND POCKET STIMULATION WAS NOTED. PROGRAMMING WAS LEFT IN UNIPOLAR AND THE LEAD REMAINS 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
    337508 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention 5076-58 IMPLANTABLE PACING LEAD