BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4831961 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05271
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 23, 2015
    Report Date
    March 23, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 MEDICAL PRODUCTS: 694965 LEAD, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD HAD INTERMITTENT P-WAVE UNDERSENSING. THE RA LEAD THRESHOLD COULD NOT BE DETERMINED DUE TO THE INCONSISTENT P-WAVE SENSING AND COMPLETE HEART BLOCK. THE RA LEAD WAS PREVIOUSLY PROGRAMMED TO VVIR BECAUSE OF THIS ISSUE, AND THE RA LEAD WILL CONTINUE TO BE PROGRAMMED TO VVIR. THE RA 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
    377860 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention 429688 LEAD, D314TRG ICD