BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990913 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08409
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 DURING AN IMPLANT PROCEDURE, THE PATIENT¿S HEART WAS PERFORATED BY A RIGHT VENTRICULAR (RV) LEAD RESULTING IN A CARDIAC TAMPONADE. THE PHYSICIAN ATTEMPTED TO PLACE AN RV LEAD IN MULTIPLE SPOTS BUT FOUND THAT THE LEAD HAD HIGH IMPEDANCE, WAS NOT CAPTURING, AND HAD VARYING R-WAVE VALUES. TO TEST IF THE RV LEAD WAS DEFECTIVE, THE PHYSICIAN PLACED THE ALREADY INSERTED RIGHT ATRIAL (RA) LEAD INTO THE RV AND NORMAL MEASUREMENTS WERE OBTAINED. THE PHYSICIAN PULLED BACK THE RA LEAD INTO THE RA FOR LATER PLACEMENT AND REMOVED THE ATTEMPTED RV LEAD. HE THEN ATTEMPTED TO PLACE A NEW RV LEAD WHICH CAUSED THE PERFORATION. THE PHYSICIAN ASSESSED THE EMERGENCY AND REMOVED ALL THE LEADS. THE PATIENT WAS PREPPED FOR A PERICARDIAL WINDOW AND EPICARDIAL LEADS WERE PLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469468 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| L| R