MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 4063 STIMULATION LEAD

Model Number	4063
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The physician's office informed inspire on (b)(6) 2019 of a patient who had experienced an adverse event in (b)(6) 2018 when the patient's simulation wire temporarily extruded from the skin after lifting a 200-pound piece of sheetrock.Inspire personnel was not aware of the issue and the physician's office was contacted (b)(6) 2019 for additional information.The physician did not see the patient in the office and prescribed bactrim remotely.The physician indicated that the event was non-serious and resolved (b)(6) 2018.
Additional Manufacturer Narrative
The physician follow-up confirmed that the original event did not result in serious patient injury.
Event or Problem Description
The physician reports that when the patient was seen in the office there was no evidence of extrusion.

• Brand Name: INSPIRE MODEL 4063 STIMULATION LEAD
• Common Device Name: INSPIRE MODEL 4063 STIMULATION LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• MDR Report Key: 8562401
• Report Number: 3007666314-2019-00035
• Device Sequence Number: 13837321
• Product Code: MNQ
• UDI-Device Identifier: 00855728005185
• UDI-Public: 00855728005185
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019
• 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: 4063
• Device Catalogue Number: 900-001-007
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/14/2005
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 08/06/2019
• 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