BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4162441 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12767
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR LEAD WAS REPOSITIONED TWICE BEFORE FINDING "ADEQUATE NUMBERS." THE FIRST TIME, IT WAS DUE TO HIGH THRESHOLD; THE SECOND TIME, IT WAS DUE TO NO CAPTURE AND HIGH IMPEDANCE. BECAUSE OF NO CAPTURE AND HIGH IMPEDANCE, A PERFORATION WAS SUSPECTED, BUT THE PATIENT REMAINED STABLE AND NO SUBSEQUENT PROCEDURE WAS NECESSARY. THE FINAL LEAD POSITIONING WAS APPROPRIATE AND THE 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
    640391 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Life Threatening