BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3994053 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08995
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    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. CONCOMITANT MEDICAL PRODUCTS: 5076-45 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE MONTH POST IMPLANT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS. IT WAS NOTED THAT THE PATIENT WAS ONLY PACING IN THE VENTRICLE 3.2 PERCENT OF THE TIME. THEREFORE, THE PHYSICIAN OPTED TO CHECK THE THRESHOLD AGAIN IN THREE MONTHS AND IF IT IS NOT WORSE THE PHYSICIAN WILL CONTINUE TO MONITOR THE LEAD EVERY SIX MONTHS. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469604 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR SEDR01 IPG