BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6009931 · Received October 6, 2016

    Report

    Report Number
    2649622-2016-13665
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    July 14, 2016
    Report Date
    July 16, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYSIS INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE AND VARIABLE AND THERE WAS AN R-WAVE AMPLITUDE MEASUREMENT ISSUE. IT WAS NOTED ON (B)(6) 2016, THE RV PACING IMPEDANCE ROSE TO 4047 OHMS SHORTLY AFTER IMPLANT UP FROM A TREND IN THE 779-1463 OHM RANGE, AND BETWEEN (B)(6) 2016, THE R-WAVE AMPLITUDE MEASURED BETWEEN 2.25 AND 2.5 MV, THEN ROSE TO 22.25 MV ON (B)(6) 2016. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DAYS FOLLOWING THE IMPLANT PROCEDURE, PATIENT PRESENTED WITH DIZZINESS AND A NEAR FAINTING EPISODE. A DEVICE CHECK INDICATED THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A BIPOLAR LEAD IMPEDANCE WARNING DUE TO HIGH PACING IMPEDANCE VALUES AND INTERMITTENT CAPTURE WAS OBSERVED. IT WAS NOTED THE DAILY PACE IMPEDANCE TREND ALSO REVEALED VARYING IMPEDANCES AND THE PHYSICIAN CHOSE TO REVISE THE POSITION OF THE RV LEAD. THE RV LEAD WAS REPOSITIONED TO THE APEX OF THE VENTRICLE AND 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
    657082 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R EN1DR01