BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4831615 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05451
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 10, 2015
    Report Date
    April 15, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 FIVE DAYS POST IMPLANT THE PATIENT EXPERIENCED A POTENTIAL PERFORATION FROM THE RIGHT VENTRICULAR (RV) LEAD, CAUSING CHEST WALL PAIN WITH INSPIRATION AND MOVEMENT, AND DURING PACING. THRESHOLDS WERE ALSO NOTED TO BE HIGH. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375735 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| L| R A2DR01 IPG, 5076-45 LEAD