MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC. INSPIRE MODEL 3024 IPG; IMPLANTABLE PULSE GENERATOR

Model Number 3024

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Pain (1994)

Event Date 11/15/2018

Event Type  Injury  

Event Description

Patient reports feeling pain on the right side of his tongue.His systems sensing waveform also appears to be abnormal.

• Brand Name: INSPIRE MODEL 3024 IPG
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC.; 9700 63rd ave n; suite 200; maple grove MN 55369
• Manufacturer (Section G): INSPIRE MEDICAL SYSTEMS INC; 9700 63rd ave n; suite 200; maple grove MN 55369
• Manufacturer Contact: joel aaberg ; 9700 63rd ave. n; suite 200; maple grove, MN 55369 ; 7632057670
• MDR Report Key: 8108016
• MDR Text Key: 128561840
• Report Number: 3007666314-2018-00047
• Device Sequence Number: 1
• Product Code: MNQ
• UDI-Device Identifier: 00855728005024
• UDI-Public: 00855728005024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other