BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2954771 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02402
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 17, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT OCCURRED OUTSIDE OF 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 PRESENTED TO THE EMERGENCY ROOM WITH A "FAST HEART RATE". IT WAS ALSO REPORTED THAT THE ATRIAL LEAD HAD HIGH IMPEDANCE AND A POLARITY SWITCH FROM BIPOLAR PACING CONFIGURATION TO UNIPOLAR PACING CONFIGURATION HAD OCCURRED. ADDITIONALLY, AN ECHOCARDIOGRAM SHOWED THAT THE DEVICE WAS IN A "NON-TRACKING MODE" AS A MODE SWITCH HAD TAKEN PLACE DUE TO NOISE ON THE ATRIAL CHANNEL. REPROGRAMMING WAS PERFORMED AND THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD WAS LATER REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59139 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R