BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3994002 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09024
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 17, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 MEDICAL PRODUCTS: ADDR01 IPG, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PALPITATIONS AND DIZZINESS. AN INTERROGATION SHOWED THE RIGHT ATRIAL (RA) LEAD WITH UNDERSENSING. THE LEAD REMAINS 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
    470977 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR 407658 LEAD