BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3155036 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-07100
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED, ANALYZED AND ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE, ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE ATRIAL PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE, AND ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). THERE WAS 1 - PATIENT ALERT FOR OUT OF TOLERANCE (OOT) SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2013. DAILY PACE IMPEDANCE TREND DATA SHOWS ATRIAL PACEBI IMPEDANCE = 456 TO 0 (UN-FILTERED DATA) OHMS BETWEEN (B)(6) 2013. THERE WAS 1 - PATIENT ALERT FOR OOT SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2013. DAILY PACE IMPEDANCE TREND DATA SHOWS VENTRICULAR PACE BI IMPEDANCE = 456 TO 0 (UN-FILTERED DATA) OHMS BETWEEN (B)(6) 2013. AND VENTRICULAR SHORT INTERVAL COUNT V-SIC=11 COUNTS, IN 0.30 DAY, ON (B)(6) 2013.

    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 PRODUCTS: 694758 IMPLANTABLE DEFIB LEAD 2012 (B)(6); 4296-88 IMPLANTABLE PACING LEAD 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL AND RIGHT VENTRICULAR (RV) LEAD IMPEDANCES WERE ZERO OHMS DUE TO ELECTRICAL NOISE DURING THE ABLATION PROCESS AT THE TIME OF AUTO IMPEDANCE MEASUREMENTS. THE ATRIAL AND RV LEADS REMAIN 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
    258870 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR D334TRG IMPLANTABLE BIV DEFIBRILLATOR