BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 6096996 · Received November 11, 2016

    Report

    Report Number
    2649622-2016-13855
    Event Type
    Death
    Date Received
    November 11, 2016
    Date of Event
    August 12, 2016
    Report Date
    August 12, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTED EVENT OF INFECTION WAS RECEIVED ON (B)(6) 2016. OF NOTE THE SERIOUS INJURY WAS SUBMITTED IN A TIMELY MANNER VIA AN ALTERNATIVE SUMMARY REPORT THAT WAS DUE ON (B)(6) 2016. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2016 AND REVEALED THE PATIENT DIED. AS THIS NEW INFORMATION DOES NOT QUALIFY FOR SUMMARY REPORTING, THIS REPORT IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. CONCOMITANT MEDICAL PRODUCTS: 5054-52 LEAD, IMPLANTED: (B)(6) 2003. 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'S DEVICE SYSTEM WAS EXPLANTED DUE TO AN INFECTION. A TEMPORARY LEAD WAS PLACED UNTIL A NEW SYSTEM WAS IMPLANTED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ON (B)(6) 2016: IT WAS FURTHER REPORTED THAT THE PATIENT IS DECEASED AND DIED APPROXIMATELY ONE MONTH POST REPLACEMENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS ON HOSPICE FOR CHRONIC MYELOGENOUS LEUKEMIA PRIOR TO PASSING AWAY. IT WAS ALSO REPORTED THAT BLOOD AND WOUND CULTURES TAKEN APPROXIMATELY ONE MONTH PRIOR TO THE PATIENT'S DEATH WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747262 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4592-45

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death ADDRS1 IPG