BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP

    MDR report key: 6196163 · Received December 21, 2016

    Report

    Report Number
    2649622-2016-16438
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    December 10, 2016
    Report Date
    December 10, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: SDR303B IPG, IMPLANTED: (B)(6) 2006. 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

    IT WAS REPORTED THAT THE PATIENT IS DECEASED. THE CAUSE OF DEATH WAS SEPSIS AND MYOCARDIAL INFARCTION. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED REGARDING THE SOURCE OF THE SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842750 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5024M

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death 5568-45 LEAD