INSPIRE SLEEP APNEA INNOVATION
Report
- Report Number
- MW5186446
- Event Type
- Injury
- Date Received
- April 7, 2026
- Date of Event
- January 1, 2023
- Report Date
- April 2, 2026
- Manufacturer
- INSPIRE MEDICAL SYSTEMS INC
- Product Code
- MNQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- LA, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
ADDITIONAL INFORMATION RECEIVED ON 4/9/2026 FOR REPORT MW5186446 TO UPDATE PROCODE: MNQ.
I HAVE COMPLAINED SEVERAL TIMES TO THE INSPIRE REPRESENTATIVES AND THE PHYSICIAN'S ASSISTANT ABOUT HOW MY DEVICE (MODEL 3028, SERIAL NUMBER AIR (B)(6)) IS NOT FUNCTIONING PROPERLY. AT TIMES, I CANNOT TELL WHETHER THE DEVICE IS ON DUE TO WHAT FEELS LIKE "ELECTRICAL LEAKAGE." I CONTINUE TO EXPERIENCE DAYTIME FATIGUE EVEN AFTER THE DEVICE WAS IMPLANTED. OCCASIONALLY, I EXPERIENCE SEVERE PAIN UNDER MY CHIN WITHOUT WARNING. I ORIGINALLY THOUGHT IT WAS A MUSCLE CRAMP CAUSED BY THE IMPLANT AND TRIED TO LIVE WITH IT. HOWEVER, I HAVE NOW LEARNED THAT IT IS CAUSED BY THE DEVICE--SPECIFICALLY, INCONSISTENT OR INAPPROPRIATE STIMULATION THAT RESULTS IN PAINFUL OR SHOCKING SENSATIONS, EVEN WHEN THE DEVICE IS OFF. THE DATE LISTED ABOVE IS APPROXIMATE START DATE AND IT IS CONTINUING TO HAPPEN TO DATE. MODEL #3028 HAS A CLASS 1 RECALL ON CERTAIN SERIAL NUMBERS. I HAVE A DIFFERENT SERIAL NUMBER THAN THE RECALL BUT I HAVE COMPLAINED NUMEROUS TIMES TO THE INSPIRE REPRESENTATIVES ABOUT MY DEVICE AND NO ONE HAS CONTACTED ME. FOUND OUT BY ACCIDENT ABOUT THE RECALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6931 | INSPIRE SLEEP APNEA INNOVATION | STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA | MNQ | INSPIRE MEDICAL SYSTEMS INC | 3028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Male | Other | CRESTOR,| EFFEXOR XR,| LUMRYZ,| ONE A DAY VITAMINS.| PROVIGIL,| WAKIX, |