BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE IV IMPLANTABLE PULSE GENERATOR

    MDR report key: 19828654 · Received July 24, 2024

    Report

    Report Number
    MW5157582
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    July 17, 2024
    Report Date
    July 19, 2024
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC.
    Product Code
    MNQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON TWO SUCCESSIVE NIGHTS (B)(6) 2024, MY INSPIRE MODEL: 3028 IMPULSE GENERATOR PAINFULLY SHOCKED ME WHEN TURNING ON AND PLACING THE MODEL: 2580 SLEEP REMOTE TO THE IMPLANT SITE. I FELT MY HAIR STAND ON END. THE SHOCK FORCED MY TONGUE OUT OF MY MOUTH, WRENCHED MY NECK AND CAUSED ME TO SCREAM OUT IN PAIN. I WAS AND AM TERRIFIED. I'VE LEARNED THAT OTHER MODELS WERE RECALLED AND MINE IS NOT ON THE LIST. IT WAS IMPLANTED ON (B)(6) 2024 WITH A SUB MODEL NUMBER: AIR378875C. I TRIED TO CONTACT ONE OF MY DOCTOR'S OFFICES THIS MORNING ((B)(6) 2024) LEAVING AN URGENT MESSAGE, BUT THEY WERE CLOSED. I WILL TRY AGAIN FIRST THING MONDAY MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484842 INSPIRE IV IMPLANTABLE PULSE GENERATOR STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS INC. 3028

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female INSPIRE LEAD REF 4063.| INSPIRE LEAD REF 4340.| INSPIRE REMOTE REF 2580.