INSPIRE HYPOGLOSSAL STIMULATOR

Report

• Report Number: MW5180512
• Event Type: Malfunction
• Date Received: December 15, 2025
• Date of Event: December 2, 2025
• Report Date: December 8, 2025
• Manufacturer: INSPIRE MEDICAL SYSTEMS, INC.
• Product Code: MNQ
• Product Problem: Yes
• Report Source: Voluntary report
• Reporter Location: US
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: Yes

Narratives

Description of Event or Problem · 0

I HAD A PATIENT THAT I WAS PERFORMING AN MRI SCAN ON THE 1.5T MRI SCANNER, WITH AN INSPIRE 3028 STIMULATOR THAT TURNED ON WITH 8 SECONDS REMAINING IN HER SCAN/EXAM. I DID GO THROUGH ALL THE PRE-SCAN REGIMEN WITH HER, I WAS UNDER TIME LIMIT AND FOLLOWED ALL PARAMETERS. SHE SQUEEZED THE BALL I TOLD HER WE HAD 8 SECONDS LEFT AND FINISHED I DON'T THINK I COULD HAVE FOUND THE STOP BUTTON THAT QUICKLY TO BE HONEST. SHE WAS FINE, NEVER WAS IN DISTRESS AND NO INJURY OR PAIN WHATSOEVER SHE JUST FELT IT TURN ON. I HAD EXPLAINED TO HER BEFOREHAND THAT I HAD HEARD OF THESE TURNING ON DURING SCANS AND IF IT DID HAPPEN EXACTLY WHAT TO DO SO SHE WAS PREPARED FOR IT. BY THE TIME I GOT HER OUT OF THE SCANNER AND BACK TO HER LOCKER IT HAD TURNED BACK OFF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1743510	INSPIRE HYPOGLOSSAL STIMULATOR	STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA	MNQ	INSPIRE MEDICAL SYSTEMS, INC.	3028

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown

Terms

Patient problem · 1

• No Clinical Signs, Symptoms or Conditions

Product problems · 1

• Use of Device Problem

Type of report · 1

• Initial submission