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

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Paralysis (1997)

Event Date 03/09/2023

Event Type  Injury  

Event Description

Had surgery with inspire device and had post surgery complicated such as continued right ear and jaw pain and tongue paralysis.

• Brand Name: INSPIRE
• Type of Device: STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC
• MDR Report Key: 16727950
• MDR Text Key: 313227400
• Report Number: MW5116563
• 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: 04/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CELEXA ; FOSAMAX ; INDERAL
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: White