BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 5119823 · Received October 1, 2015

    Report

    Report Number
    2649622-2015-11629
    Event Type
    Malfunction
    Date Received
    October 1, 2015
    Date of Event
    November 1, 2014
    Report Date
    July 24, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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 AVAILABLE. ANALYST COMMENTED, ATRIAL PACE IMPEDANCE STEADY AT APPROXIMATELY 400 OHMS THROUGHOUT RECORD, EXCEPT FOR WEEK OF (B)(6) 2015 WHEN IMPEDANCE SPIKED TO A MAXIMUM OF 1212 OHMS, THEM RETURNED TO BASELINE OF APPROXIMATELY 425 OHMS. CONCOMITANT MEDICAL PRODUCTS: (B)(4) IPG IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHICK IMPEDANCE TREND DATA FOR THE ATRIAL SIDE SHOWED A SHARP INCREASE AND WAS HIGH. THEREFORE, STRESS TEST WAS PERFORMED ON THE PATIENT, BUT NO REPLICATION OF AN EVENT. THE LEAD WILL CONTINUE TO BE MONITORED AND REMAINS IN SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649863 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4524

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR