BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990293 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08695
    Event Type
    Injury
    Date Received
    August 7, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND ENCOUNTERED A CEREBRAL VASCULAR ACCIDENT (CVA) EPISODE. THE RIGHT VENTRICULAR (RV) LEAD HAD PERFORATED THE SEPTURM WITH PLEURAL AND PERICARDIAL EFFUSION ENCOUNTERED. IT WAS REPORTED THAT ANTICOAGULATION THERAPY HAD BEEN ADJUSTED IN ANTICIPATION OF THE PROCEDURE, PRIOR TO THE CVA. ACCORDING TO THE PHYSICIAN, THE CVA MAY BE ASSOCIATED WITH THE RV LEAD PERFORATION. THE PATIENT WAS SCHEDULED TO TRANSFER A DIFFERENT FACILITY FOR EXPLANT AND REPLACEMENT OF THE RV LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463334 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R