BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3862149 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07045
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 FOUR DAYS POST IMPLANT, THE PATIENT CAME TO THE HOSPITAL COMPLAINING OF CHEST PAIN. COMPUTED TOMOGRAPHY (CT) SHOWED THE RIGHT VENTRICULAR (RV) LEAD HAD PERFORATED THE RIGHT VENTRICULAR APEX, RESULTING IN HIGH THRESHOLDS. THE PERFORATION RESULTED IN PERICARDIAL EFFUSION, AND A PERICARDIAL WINDOW WAS PERFORMED TO PUT IN A CHEST TUBE TO DRAIN THE PERICARDIUM. 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
    341989 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407452

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| L| R ADDRL1 IPG, 4574 LEAD