BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990237 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08726
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: 5076-52 LEAD (B)(6) 2009. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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 RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE.AUTOMATIC LEAD DIAGNOSTICS SHOWS VENTRICULAR LEAD IMPEDANCE BEGAN TO INCREASE IN DECEMBER 2013 FROM AN APPROXIMATE BASELINE 500 OHMS UP TO >1500 OHMS BY FEBRUARY 2014. VCM TREND SHOWS RV LEAD THRESHOLD BEGAN TO RISE IN DECEMBER 2013 FROM AVERAGE THRESHOLD BASELINE OF 0.5 VOLTS UP TO 1.5 VOLTS BY APRIL 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD SHOWED RISING THRESHOLDS AND IMPEDANCES. IT WAS ALSO REPORTED THERE MAY BE A POSSIBLE LEAD FRACTURE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463202 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R VEDR01 IPG