BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE FIX NOVOUS

    MDR report key: 2953366 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01088
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 26, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE 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 PRODUCT: 5076 IMPLANTABLE PACING LEAD 2008 (B)(6), (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP CHECK, IT WAS FOUND THAT THE VENTRICULAR LEAD IMPEDANCE HAS RISEN TO UNDEFINED IMPEDANCE LEVEL. THERE WAS ALSO SOME OVERSENSING. THE PACING MODE WAS CHANGED AND THE LEAD IS STILL 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
    56300 CAPSURE FIX NOVOUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00093 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR