BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2955453 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01395
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD 2012 (B)(6). (B)(4) .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO FEELING LIGHT HEADED AND DIZZY. IT WAS DISCOVERED THE DEVICE SET SCREWS WERE LOOSE FOR THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD. DURING THE LEAD REVISION, BOTH OF THE LEADS WERE EASILY REMOVED FROM THE DEVICE CONNECTOR PORTS. BOTH OF THE LEADS WERE TESTED AND FOUND TO BE WORKING SATISFACTORILY AND WERE REINSERTED INTO THE DEVICE AND THE SET SCREWS WERE PROPERLY TIGHTENED. THE DEVICE AND BOTH LEADS REMAIN 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
    59954 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR