FDA Adverse Event Malfunction Summary report: N

INSPIRE

MDR report key: 15484614 · Received September 26, 2022

Report

Report Number
15484614
Event Type
Malfunction
Date Received
September 26, 2022
Date of Event
August 24, 2022
Report Date
September 20, 2022
Manufacturer
INSPIRE MEDICAL SYSTEMS, INC.
Product Code
MNQ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
ID
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT HAS AN INSPIRE SLEEP APNEA DEVICE, MODEL 3028, IMPLANTED IN HER BODY. DEVICE WAS VETTED PRIOR TO HER ARRIVAL TO THE MRI DEPARTMENT. DEVICE WAS FOUND TO BE OPERATING AND SHE WAS CLEARED FOR HER MRI SCAN. UPON HER ARRIVAL TO THE MRI DEPARTMENT FOR HER SCAN HER DEVICE WAS CONNECTED TO THE HANDHELD UNIT AND WAS TURNED ON AND TONGUE STIMULATION WAS WITNESSED BY MYSELF AND [NAME REDACTED]. HER DEVICE WAS THEN TURNED OFF AND THE PATIENT WAS MOVED INTO THE MRI SCANNER ON THE MRI TABLE. PATIENT WAS IN THE SUPINE/HEADFIRST POSITION. PATIENT WAS IN THE T/R HEAD COIL AS PER MANUFACTURE SPECIFICATIONS. THE SCAN WAS STARTED, AND PATIENT WAS CHECKED ON AFTER EACH SEQUENCE. AFTER 22 MINUTES OF SCANNING THE PATIENT ACTIVATED THE EMERGENCY SQUEEZE BALL AND THE EXAM WAS ENDED AS THE PATIENT WAS RECEIVING STIMULATION FROM HER DEVICE. SHE WAS REMOVED FROM THE SCANNER AND PLACED IN ZONE III AND WE WERE ABLE TO USE HER HAND HELD DEVICE TO TURN OFF STIMULATION. SHE WAS INFORMED OF THE NEED TO IMMEDIATELY REACH OUT TO HER MD AND DEVICE REPRESENTATIVE, AND SHE WAS IN NO DISTRESS AT THAT TIME. SHE THEN CHANGED INTO HER CLOTHING AND LEFT THE MRI DEPARTMENT. I THEN CALLED HER ABOUT 20 MINUTES LATER TO CHECK IN WITH HER AND DURING THE PHONE CALL SHE WAS AGAIN STIMULATED SPONTANEOUSLY FROM HER INSPIRE DEVICE. I INFORMED HER TO IMMEDIATELY CALL HER REPRESENTATIVE AND MD AND INFORM THEM OF THE SITUATION AND TO NOT HESITATE TO CALL IF SHE NEEDED ANY OTHER HELP. SHE AGREED WITH THIS COURSE OF ACTION AND ENDED THE CALL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1956000 INSPIRE STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS, INC. 3028 C05305

Patients

Seq Age Sex Outcome Treatment
1 27375 DA Female