BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASSURITY MRI

    MDR report key: 22172117 · Received June 9, 2025

    Report

    Report Number
    3006705815-2025-04242
    Event Type
    Death
    Date Received
    June 9, 2025
    Report Date
    September 16, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    UDI-DI
    05414734509589
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION D - MANUFACTURER INFORMATION WAS CORRECTED. THE MANUFACTURER INFORMATION SHOULD HAVE BEEN "ST. JUDE MEDICAL, INC.(CRM-SYLMAR)" INSTEAD OF "ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)" WHICH WAS SELECTED IN ERROR.

    Additional Manufacturer Narrative · 0

    FINAL ANALYSIS REVEALS THAT ONCE THE DEVICE WAS RECEIVED, IT DISPLAYED NORMAL DEVICE CHARACTERISTICS UPON THE FIRST STAGE OF ANALYSIS. FURTHERMORE, THE DEVICE IMAGE WAS SAVED AND ANALYZED, NO DISCREPANCIES WERE NOTED. AFTER ALL ELECTRICAL TESTS PERFORMED, INCLUDING THERMAL AND MECHANICAL, THE DEVICE CONTINUES EXHIBITING NORMAL DEVICE CHARACTERISTICS. LONGEVITY ASSESSMENT WAS PERFORMED AND DEVICE WAS IN THE NORMAL RANGE OF OPERATION WITH APPROPRIATE REMAINING LONGEVITY. CORRECTION: SECTION G - SITE NAME AND INFORMATION CORRECTED/UPDATED.

    Description of Event or Problem · 0

    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 WAS CONGESTIVE HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318684 ASSURITY MRI IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2272 A000112491 05414734509589

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death