BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 4833804 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06955
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    February 15, 2008
    Report Date
    April 30, 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. (B)(4).

    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 RIGHT VENTRICULAR (RV) PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE. ANALYST COMMENTED, VENTRICULAR LEAD IMPEDANCE TRENDS PROGRAMMED OFF, BUT PERFORMANCE COUNTER DATA INCLUDES HIGH NUMBER OF LOW IMPEDANCE/SHORT CIRCUIT PACES. LIFETIME MINIMUM IMPEDANCE MEASUREMENT OF 201 OHMS. VENTRICULAR LEAD WARNING OCCURRED ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SEVERAL INSTANCES OF LOW AND VARYING IMPEDANCE, AND A LEAD INTEGRITY ALERT (LIA) TRIGGERED FOR LOW IMPEDANCE. THE RV THRESHOLDS EXHIBITED VARIANCE AND POLARITY SWITCH HAD OCCURRED. REVISION, AND/OR LEAD SETTING ADJUSTMENTS WERE RECOMMENDED, AND THE RV LEAD 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
    378515 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR ADDRL1 IPG