BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE PULSE GENERATOR

    MDR report key: 19722895 · Received July 10, 2024

    Report

    Report Number
    MW5157212
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    February 1, 2024
    Report Date
    July 8, 2024
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC.
    Product Code
    MNQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED EMAIL FROM FDA TODAY STATING INSPIRE PULSE GENERATOR (IPG) MODEL 3028 WAS BEING RECALLED. SAID EMAIL STATED NO INJURIES HAD BEEN REPORTED...I HAD AN INJURY AND AN AUTO ACCIDENT DUE TO FALLING ASLEEP. MY FIRST SURGERY WAS (B)(6) 2023. MODEL 3028 AIR364930C WAS IMPLANTED. I HAD REVISION SURGERY (B)(6) 2024. INSPIRE REMOVED AND REPLACED MY GENERATOR AND LEAD. INSPIRE TRIED TO GET ME TO SIGN A RELEASE. I DID NOT SIGN THE RELEASE...SAID RELEASE WOULD HAVE PROHIBITED ME FROM CONTACTING FDA, NEWS MEDIA ETC. SINCE I DID NOT SIGN THE RELEASE INSPIRE WILL NOT PAY ME FOR MONIES, I HAD TO PAY FOR THE REVISION SURGERY AND NOW I LEARN THE DEVICE IS BEING RECALLED. THE FDA EMAIL STATED THIS RECALL AS THE MOST SERIOUS TYPE. I WANT TO TELL FDA MORE ABOUT MY CASE...INSPIRE NEEDS TO BE STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386367 INSPIRE PULSE GENERATOR STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS INC. 3028

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention