MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC INSPIRE SLEEP APNEA DEVICE; STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA

Model Number 3028

Device Problems Use of Device Problem (1670); Calibration Problem (2890); Output Problem (3005)

Patient Problems Pain (1994); Sleep Dysfunction (2517)

Event Date 10/01/2022

Event Type  Injury  

Event Description

Reporter calling stating he is experiencing ongoing problems with intense pain and interrupted sleep ever since approximately (b)(6) 2022, and continuing to the present day.He reports his inspire device was working fine after it was initially implanted up until he was preparing to have knee surgery, at which time his surgeon instructed him to deactivate the device.He was given instruction to start using the device again once he was sufficiently recovered from knee surgery.On approximately (b)(6) 2022, he was recovered enough to begin using his inspire device again, however every time he attempts to activate the device, it forcefully exerts pressure on his tongue, which disturbs his sleep and wakes him up in intense pain.He has contacted inspire regarding the problems he has experienced but states they are not being very helpful.He has had visits with his doctor to attempt to recalibrate the device, however these attempts have been unsuccessful.Reporter says the device causes the most pain when he is laying on his back and trying to sleep.Reporter states that on approximately (b)(6) 2023, a sleep study was performed, and that an inspire representative was flown out to attend.Reporter states the sleep study found that he was sleeping "less than four hours" and that "every time" the representative attempted to activate the inspire device, that it interrupted his sleep causing him to wake up.Reporter is very concerned that the device is malfunctioning and causing him problems.

• Brand Name: INSPIRE SLEEP APNEA DEVICE
• Type of Device: STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC
• MDR Report Key: 16771261
• MDR Text Key: 313678943
• Report Number: MW5116846
• Device Sequence Number: 1
• Product Code: MNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 3028
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White