MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC INSPIRE; PRESSURE SENSING LEAD

Model Number	4323
Medical Device Problem Codes	Device Sensing Problem (2917); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During the ipg re positioning for cosmetic purposes, a breach in the sensing lead insulation was noticed.It was not addressed during this initial revision procedure.Therapy was discontinued and another procedure was done to replace the sensing lead and restore therapy.This resolved the issue.

• Brand Name: INSPIRE
• Common Device Name: PRESSURE SENSING LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC; 9700 63rd ave n; suite 200; maple grove MN 55369
• MDR Report Key: 7885848
• Report Number: 3007666314-2018-00034
• Device Sequence Number: 186160
• Product Code: MNQ
• UDI-Device Identifier: 10855728005403
• UDI-Public: 10855728005403
• Combination Product (Y/N): N
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 09/18/2018
• 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: Required Intervention