BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6085233 · Received November 8, 2016

    Report

    Report Number
    2649622-2016-13840
    Event Type
    Death
    Date Received
    November 8, 2016
    Date of Event
    July 8, 2016
    Report Date
    October 11, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL PORTION OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL ANALYSIS PERFORMED ONLY. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME WITH INFORMATION INDICATING THE PATIENT IS DECEASED AND THE CAUSE OF DEATH WAS PROVIDED AS CARDIOPULMONARY DUE TO SEPTIC SHOCK. ADDITIONAL INFORMATION OBTAINED REPORTED THE PATIENT HAD PNEUMONIA WITH POSITIVE BLOOD CULTURES ONE MONTH PRIOR TO DEVICE SYSTEM IMPLANT. THE ORGANISM AT THAT TIME WAS IDENTIFIED AS ENTEROCOCCUS. THE PATIENT WAS ADMITTED THREE MONTHS POST IMPLANT WITH SEPTIC SHOCKS AND ENDOCARDITIS. THE SOURCE OF THE INFECTION AND ENDOCARDITIS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736515 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death A2DR01 IPG, 5076-45 LEAD