BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2973438 · Received February 22, 2013

    Report

    Report Number
    2649622-2013-02467
    Event Type
    Death
    Date Received
    February 22, 2013
    Date of Event
    September 13, 2012
    Report Date
    November 18, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. PRODUCT EVENT SUMMARY: EVALUATION SUMMARY: (B)(4). THE LEAD WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SITTING AT THE TABLE TALKING WHEN SUDDENLY THE PATIENT STOPPED TALKING AND COLLAPSED. THE EXACT CAUSE OF DEATH IS UNKNOWN. THE DEVICE SYSTEM WAS IMPLANTED AND IN USE AT THE TIME OF THE EVENT. THERE ARE NO INDICATIONS THAT THE DEVICE FAILED, NO COMPLAINTS OR ALLEGATIONS AGAINST THE DEVICE SYSTEM HAVE BEEN MADE. THIS IS BEING REPORTED DUE TO THE LACK OF INFORMATION AVAILABLE ABOUT THE CAUSE OF DEATH AND INABILITY TO RULE OUT DEVICE INVOLVEMENT COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77762 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Death