BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSPIRE MODEL 3028 IPG

    MDR report key: 20789974 · Received November 27, 2024

    Report

    Report Number
    3007666314-2024-00574
    Event Type
    Death
    Date Received
    November 27, 2024
    Date of Event
    October 26, 2024
    Report Date
    November 26, 2024
    Manufacturer
    INSPIRE MEDICAL SYSTEMS
    Product Code
    MNQ
    UDI-DI
    10855728005915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO INSPIRE A PATIENT PASSED AWAY ON (B)(6) 2024, THREE DAYS POST-IMPLANT OF THE INSPIRE SYSTEM. THE PATIENT WAS PRESCRIBED ANTIBIOTICS, PAIN MEDICATION, AND NAUSEA MEDICATION POST-IMPLANT PROCEDURE. THE IMPLANTING PHYSICIAN STATED THAT THE PATIENT PRESENTED TO THE ER WITH A VERY WEAK PULSE AND ALSO EXPERIENCING A SINKING EPISODE. THE PATIENT PASSED AWAY FROM A PULMONARY EMBOLISM AND THE IMPLANTING PHYSICIAN SAID THAT HE DOES NOT FEEL THAT IT WAS DIRECTLY RELATED TO THE INSPIRE IMPLANT, BUT POSSIBLY A COMPLICATION FROM SURGERY IN GENERAL. THE INSPIRE THERAPY HAD NOT BEEN ACTIVATED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2357342 INSPIRE MODEL 3028 IPG INSPIRE MODEL 3028 IPG MNQ INSPIRE MEDICAL SYSTEMS 3028 10855728005915

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death