BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASSURITY MRI

    MDR report key: 7945786 · Received October 8, 2018

    Report

    Report Number
    3006705815-2018-02559
    Event Type
    Death
    Date Received
    October 8, 2018
    Date of Event
    September 11, 2018
    Report Date
    November 11, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    DXY
    UDI-DI
    05414734509589
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH IS CARDIAC ARREST, END STAGE KIDNEY DISEASE, AND DIABETES MELLITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786398 ASSURITY MRI IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PM2272 A000050308 05414734509589

    Patients

    Seq Age Sex Outcome Treatment
    1 Death LPA1200M/46, (B)(4)| LPA1200M/52, (B)(4)