BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTISENSE LEAD

    MDR report key: 22844282 · Received August 19, 2025

    Report

    Report Number
    2017865-2025-98057
    Event Type
    Death
    Date Received
    August 19, 2025
    Date of Event
    June 14, 2025
    Report Date
    September 25, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED IN HOSPITAL BETWEEN (B)(6), 2025. THE PATIENT WAS SEEN FOR VASCULAR ISSUES IN CLINIC PRIOR TO ADMISSION. THE PATIENT PASSED AWAY (B)(6), 2025. THE CAUSE OF DEATH WAS UNKNOWN. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DUE TO THE DEVICE/SYSTEM. FURTHER INFORMATION WAS REQUESTED FROM THE CLINICIAN BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253679 OPTISENSE LEAD NO MATCH NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1999/46 2886679

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| D