BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4161014 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11656
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    January 4, 2006
    Report Date
    July 8, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 MEDICAL PRODUCTS: PRODUCT ID E2DR33 IPG, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DUAL-CHAMBER PACEMAKER WAS IMPLANTED, THE PATIENT DEVELOPED NONISCHEMIC CARDIOMYOPATHY WITH EJECTION FRACTION DIMINISHING. IT WAS FELT IT WAS DUE TO RIGHT VENTRICULAR (RV) PACING. THE DEVICE AND RV LEAD WERE REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641253 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 407652 LEAD