BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4162662 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12673
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    April 16, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 THE PATIENT'S HEART WAS PERFORATED DURING IMPLANTATION OF A REPLACEMENT RIGHT VENTRICULAR (RV) LEAD. THE PATIENT EXPERIENCED PERICARDIAL EFFUSION, TAMPONADE, AND A PNEUMOTHORAX WHICH REQUIRED PLACEMENT OF A CHEST TUBE. THE PREVIOUS RV LEAD WAS DETERMINED TO HAVE INTERMITTENT CAPTURE, NOISE, AND UNSTABLE THRESHOLDS AND IMPEDANCE. THE PREVIOUS RV LEAD WAS SUSPECTED FOR FRACTURE AND CAPPED BY THE PHYSICIAN. THE REPLACEMENT RV LEAD WAS SUCCESSFULLY REPOSITIONED TO THE APEX OF THE HEART, AND 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
    643131 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| L| R SESR01 IPG