MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 3028 IPG

Model Number 3028

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Dysphasia (2195)

Event Date 02/02/2019

Event Type  Injury  

Event Description

While symptoms appear to be improving during post-implant healing, the patient was seen at her post-op check and presented with signs of tongue weakness, difficulty with speech, and pain in the jaw.Activation has been delayed.

Event Description

The patient''s symptoms resolved without further intervention.

• Brand Name: INSPIRE MODEL 3028 IPG
• Type of Device: INSPIRE MODEL 3028 IPG
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• MDR Report Key: 8359146
• MDR Text Key: 136786314
• Report Number: 3007666314-2019-00017
• Device Sequence Number: 1
• Product Code: MNQ
• UDI-Device Identifier: 10855728005465
• UDI-Public: 10855728005465
• 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: 01/01/2005,10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3028
• Device Catalogue Number: 900-007-003
• 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