BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASSURITY MRI

    MDR report key: 22568878 · Received July 22, 2025

    Report

    Report Number
    2017865-2025-94662
    Event Type
    Death
    Date Received
    July 22, 2025
    Report Date
    December 24, 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
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED DUE TO UNKNOWN DEATH. THE DEVICE WAS AT END OF SERVICE (EOS) UPON RECEIPT. DEVICE IMAGE WAS SAVED AND ANALYZED, AUTOCAPTURE WAS ENABLED AND BATTERY VOLTAGE IS AT EOL. LONGEVITY ASSESSMENT WAS PERFORMED; DEVICE EXCEEDED THE PROJECTED LONGEVITY AND IS CONSIDERED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT DECEASED. 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 UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768032 ASSURITY MRI IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2272 A000103252 05414734509589

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male Death