BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4831860 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05314
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    January 1, 2011
    Report Date
    April 24, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE ATRIAL PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE AND OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). THE ATRIAL LEAD IMPEDANCE TREND DATA HAD AN AVERAGE IMPEDANCE OF APPROXIMATELY 250 OHMS THROUGHOUT RECORD; LIFETIME MINIMUM OF 197 OHMS. ATRIAL LEAD WARNING OCCURRED ON (B)(6) 2015 AND SINCE WARNING THERE IS A HIGH COUNT OF LOW IMPEDANCE/SHORT CIRCUIT PACES. ATRIAL HIGH RATE EPISODES WITH APPARENT NON-PHYSIOLOGICAL OVERSENSING WAS SEEN ON THE EGMS. CONCOMITANT MEDICAL PRODUCTS: SEDR01: IPG, IMPLANTED: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE AND OVERSENSING DEMONSTRATED ON SOME OF THE ATRIAL EPISODES. 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
    380073 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR 4092-52 LEAD