BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3051044 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04756
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    February 11, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    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. CONCOMITANT PRODUCTS: 6947, IMPLANTABLE DEFIB LEAD, (B)(6) 2004; 4193, IMPLANTABLE PACING LEAD, (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF). IT WAS ALSO REPORTED THAT THE VF COINCIDED WITH ATRIAL CAPTURE MANAGEMENT (ACM) CAUSING A LENGTHENING OF THE ATRIOVENTRICULAR (AV) DELAY. ADDITIONALLY, HIGH ATRIAL LEAD THRESHOLDS WERE NOTED. ACM WAS PROGRAMMED OFF; THE DEVICE AND ATRIAL 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
    153515 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 D354TRG IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR