BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1992667 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02978
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE THE DEVICE CHANGE, THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING OVERSENSING AND INCREASED THRESHOLDS. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD SHOWED HIGH THRESHOLDS COMPARED TO PREVIOUS FOLLOW-UP, THAT THIS HAS BEEN OBSERVED INTERMITTENTLY ON TRENDS FOR THE PAST APPROXIMATELY 13 MONTHS, AND THAT THE THRESHOLD HAS BEEN CONSISTENTLY HIGH FOR THE PAST 3 MONTHS. IT WAS ALSO REPORTED THAT IMPEDANCE ON THE ATRIAL LEAD HAS RISEN FROM AROUND 500 OHMS TO AROUND 800 OHMS OVER THE SAME APPROXIMATELY 13 MONTH TIMEFRAME. THE PHYSICIAN REPROGRAMMED TO AVOID PACING IN THE ATRIUM, AND CONTINUES TO MONITOR THE LEAD THRESHOLDS. THE LEADS REMAINS IN USE. IT WAS FURTHER REPORTED THAT REPORTED THAT THE RV LEAD IMPEDANCE HAS GRADUALLY RISEN AND IS NOW AT ~1400 OHMS; THE SENSING IS BETWEEN 2.0 AND 4.0MV WITH HIGH THRESHOLDS NOTED. THE RV LEAD WILL CONTINUE TO BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE THE DEVICE CHANGE, THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING OVERSENSING AND INCREASED THRESHOLDS. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD SHOWED HIGH THRESHOLDS COMPARED TO PREVIOUS FOLLOW-UP, THAT THIS HAS BEEN OBSERVED INTERMITTENTLY ON TRENDS FOR THE PAST APPROXIMATELY 13 MONTHS, AND THAT THE THRESHOLD HAS BEEN CONSISTENTLY HIGH FOR THE PAST 3 MONTHS. IT WAS ALSO REPORTED THAT IMPEDANCE ON THE ATRIAL LEAD HAS RISEN FROM AROUND 500 OHMS TO AROUND 800 OHMS OVER THE SAME APPROXIMATELY 13 MONTH TIMEFRAME. THE PHYSICIAN REPROGRAMMED TO AVOID PACING IN THE ATRIUM, AND CONTINUES TO MONITOR THE LEAD THRESHOLDS. THE LEADS 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
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB