BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3152676 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06709
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPERIENCING HIGH THRESHOLDS AND RISING IMPEDANCES. THE LEAD IS SCHEDULEDTO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252204 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4092

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R