BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3994285 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10111
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    August 13, 2009
    Report Date
    October 19, 2009
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE PATIENT SUDDENLY COMPLAINED OF BREATHLESSNESS AND BRADYCARDIA. THE PATIENT HAD DEVELOPED A PERICARDIAL EFFUSION DURING POSITIONING ATTEMPTS OF THE RIGHT VENTRICULAR LEAD (RV). MEDICATION WAS GIVEN AND A PERICARDIAL DRAIN INSERTED. THE LEAD REMAINS IN USE. THE PATIENT WAS ENROLLED IN THE (B)(6) CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472198 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R