BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3863118 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06541
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    August 1, 2013
    Report Date
    March 12, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD 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 RIGHT VENTRICULAR (RV) LEAD WAS BEYOND THE EXPECTED LOWER RANGE. FROM 02FEB2015 THROUGH 21MAR2016, MINIMUM RV PACING IMPEDANCE VARIED BETWEEN 53 OHMS AND 213 OHMS, WHICH IS OUT OF RANGE LOW. SINCE 25JUN2015 THERE WERE 237719 SHORT CIRCUIT PACES AND 4458 NON-PHYSIOLOGICAL SENSES WITH 31 SUCCESSFUL PACES.

    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 MEDICAL PRODUCTS: 5076 LEAD, (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LOW PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY TWO YEARS LATER, THOUSANDS OF LOW IMPEDANCE PACES HAD OCCURRED OVER THE PREVIOUS TEN MONTHS. AN INSULATION BREACH WAS SUSPECTED. THE LEAD CONTINUES TO BE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339943 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5092-58

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR