BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 3860097 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05590
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    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. ADDR01 IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTED: 2009-(B)(6).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD 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 RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE. AUTO LEAD DIAGNOSTICS SHOWS THE VENTRICULAR LEAD HAS A NUMBER OF SHORT CIRCUIT/LOW IMPEDANCE PACES AND A WARNING OCCURRED ON 2013-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENTRICULAR LEAD WARNING WAS TRIGGERED DUE TO LOW PACING IMPEDANCES. A REVIEW OF THE HISTORY SHOWED THAT THE POLARITY HAD SWITCHED FROM BIPOLAR TO UNIPOLAR IN 2011 DUE TO A LEAD WARNING. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED A SHART PAIN DURING PACING. THE LEAD REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340563 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR 5554-53 LEAD