MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 3024 IPG

Model Number 3024

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Swollen Glands (2092); No Code Available (3191)

Event Date 02/12/2019

Event Type  Injury  

Event Description

Patient is experiencing enlarged salivary glands leading to excessive saliva and choking that correlates with inspire therapy use.Patient underwent endoscopy and has a biopsy scheduled with an ent.

Event Description

There have been no further complaints from this patient, per the physician, and the swelling of the patient's salivary glands has subsided.

• Brand Name: INSPIRE MODEL 3024 IPG
• Type of Device: INSPIRE MODEL 3024 IPG
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• MDR Report Key: 8345912
• MDR Text Key: 136446903
• Report Number: 3007666314-2019-00014
• Device Sequence Number: 1
• Product Code: MNQ
• UDI-Device Identifier: 00855728005024
• UDI-Public: 00855728005024
• Combination Product (y/n): Y
• PMA/PMN Number: P130008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3024
• Device Catalogue Number: 900-003-015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention