BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4162624 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12668
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 13, 2014
    Report Date
    July 13, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. CONCOMITANT: D314DRM ICD IMPLANTED: 2012-(B)(6). (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO THE EMERGENCY ROOM DUE TO RECEIVING AN ASYMPTOMATIC SHOCK. A REMOTE MONITORING TRANSMISSION INDICATED THAT THE PATIENT WAS IN ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION AND RECEIVED THERAPY FOR THREE DEVICE DEFINED VENTRICULAR FIBRILLATION EPISODES. THE REVIEW OF THE EPISODES INDICATED THAT THE RHYTHM APPEARS TO BE POSSIBLE ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. ATRIAL UNDERSENSING WAS NOTED. THE DEVICE AND LEAD 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
    644516 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR 6947M55 LEAD