BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3160345 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07941
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    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. (B)(4) IMPLANTABLE PACING LEAD (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RIGHT VENTRICULAR (RV) LEAD WARNING WAS ACTIVATED DUE TO LOW IMPEDANCE. IT WAS FURTHER REPORTED THAT A FRACTURE WAS VISUALIZED ON THE RV LEAD. THE POLARITY SWITCH SETTINGS WERE ADJUSTED AND THE LEAD REMAINS 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
    259761 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)