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	Unspecified Infection (1930)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
This inspire patient has also had a heart transplant and is currently on coumadin.Over 5 months, the patient was seen three times by his physician for pain, swelling, and drainage in the area of his stimulation lead neck incision.The physician conducted an ultrasound of the area and prescribed bactrim.At the second visit, the incision appeared slightly raised but otherwise okay.However, the physician prescribed another round of bactrim out of caution.At the next visit, the physician noted that swelling at the site had increased, there was also drainage, but no fever.The physician prescribed another round of bactrim and referred the patient to an infectious disease physician.That physician confirmed that there was an infection at the stimulation lead site but recommended a daily antibiotic for life, and an ultrasound every 3-4 months to ensure that the infection is not spreading, as opposed to explanting the system.

• 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: 8798986
• Report Number: 3007666314-2019-00057
• Device Sequence Number: 19610227
• Product Code: MNQ
• UDI-Device Identifier: 10855728005465
• UDI-Public: 10855728005465
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2019
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/17/2019
• 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; Required Intervention
• Date Report Sent to FDA: 01/01/2005