BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152461 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06798
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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) IMPLANTABLE PACING LEAD, (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE EMERGENCY ROOM FOR UNEXPLAINED SYNCOPE. AN EVENT MONITOR SHOWED INTERMITTENT CAPTURE ON THE RIGHT VENTRICULAR LEAD WHEN THE PATIENT BECAME SYNCOPAL. THE EVENT MONITOR ALSO SHOWED NO CAPTURE. THE LEAD HAS A POSSIBLE FRACTURE. A NEW RIGHT VENTRICULAR LEAD WAS IMPLANTED. THE ATRIAL LEAD WAS CAPPED DUE TO THE PATIENT BEING IN ATRIAL FIBRILLATION. THE EXISTING RIGHT VENTRICULAR LEAD WAS PLUGGED INTO THE ATRIAL PORT AS A BACKUP UNTIL THE NEW LEAD HAS TIME TO HEAL AS THE PATIENT IS DEPENDENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252721 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| L| R (B)(4) IMPLANTABLE PULSE GENERATOR