BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3160465 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07983
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 PRODUCT: 4076 IMPLANTABLE PACING LEAD, (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT ATRIAL LEAD WAS EXHIBITING HIGH THRESHOLDS. REPROGRAMMING WAS COMPLETED 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
    259569 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention VEDR01 IMPLANTABLE PULSE GENERATOR