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

Model Number	3028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was seen by a physician on (b)(6) 2019.The physician noted that there was pus coming out of chest (ipg) incision.The physican started the patient on augmentin, peroxide, and bacitracin ointment.The physician reported the event as resolved without sequelae on (b)(6) 2019.
Event or Problem Description
The type of reportable event recorded in box h 1 indicated death in the initial report for this incident.This was in error, no patient death occurred.

• Brand Name: INSPIRE MODEL 3028 IPG
• Common Device Name: INSPIRE MODEL 3028 IPG
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• MDR Report Key: 8537462
• Report Number: 3007666314-2019-00031
• Device Sequence Number: 11370445
• Product Code: MNQ
• UDI-Device Identifier: 10855728005465
• UDI-Public: 10855728005465
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 3028
• Device Catalogue Number: 900-007-003
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005