BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 4892780 · Received July 6, 2015

    Report

    Report Number
    2649622-2015-07736
    Event Type
    Death
    Date Received
    July 6, 2015
    Date of Event
    November 5, 2011
    Report Date
    July 20, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED FROM A FUNERAL HOME WITH NO INFORMATION. THE PATIENT DIED GREATER THAN THREE YEARS FROM TODAY. NO CONTACTS/EVENTS REGARDING THE SYSTEM HAVE EVER BEEN RECEIVED/REPORTED. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    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

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED. VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED FROM A FUNERAL HOME WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURE¿S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY 7 MONTHS POST IMPLANT OF THE IPG SYSTEM, APPROXIMATELY 3.5 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437535 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4092-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Death