MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC INSPIRE MODEL 3028 IPG; IMPLANTABLE PULSE GENERATOR

Model Number	3028
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient complained of pain at intercostal site.During physical exam the doctor determined the ipg had flipped 180 degrees.Patient will likely require a revision surgery to address this in the near future.

• Brand Name: INSPIRE MODEL 3028 IPG
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC; 9700 63rd ave n; suite 200; maple grove MN 55369
• MDR Report Key: 7476973
• Report Number: 3007666314-2018-00008
• Device Sequence Number: 11043977
• Product Code: MNQ
• UDI-Device Identifier: 10855728005366
• UDI-Public: 10855728005366
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2018

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: Physician
• Device Model Number: 3028
• Device Catalogue Number: 900-007-001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1