BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 5559150 · Received April 7, 2016

    Report

    Report Number
    2649622-2016-03899
    Event Type
    Injury
    Date Received
    April 7, 2016
    Date of Event
    February 19, 2016
    Report Date
    February 23, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 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 ATRIAL PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE. SINCE (B)(6) 2014 MIN ATRIAL PACING IMPEDANCE IS BETWEEN 171-228 OHMS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WARNING TRIGGERED FOR LOW PACING IMPEDANCES ON THE ATRIAL LEAD. THE ATRIAL LEAD LATER HAD A POLARITY SWITCH TO UNIPOLAR AND STILL EXHIBITED LOW IMPEDANCES. THE DEVICE WAS REPROGRAMMED AS A RESULT AND THE ATRIAL 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
    214090 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4568

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention