BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 3051216 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04817
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    December 3, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 THERE WAS HIGH IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENTC OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153181 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R KDR701 PACEMAKER