BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3862113 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07057
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 PRODUCTS: ADDRL1 IPG, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN SIX WEEKS OF IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD CAPTURE MANAGEMENT (CM) WAS GETTING HIGHER THRESHOLD MEASUREMENTS THAN THE IN-OFFICE CAPTURE THRESHOLD TEST. IT WAS ALSO DISCUSSED THAT THE UNDERSENSING OF THE CM EVOKED RESPONSE MAY IMPROVE AS THE RV LEAD MATURES. THE RV 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
    342431 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR 5076-45 LEAD