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

Model Number	3028
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Twiddlers Syndrome (2114)
Date of Event	07/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During a revision to restore therapy, extensive damage to the inspire system was discovered resulting from twiddler's syndrome.The ipg had been flipped +50 times, causing damage to both leads.The physician removed the proximal sections of the leads and resecured the ipg in the pocket for potential future re-implantation.The explant procedure took place on (b)(6) 2019.I walked her stepping up with her remote.She got from level 6 to 7.But says it won¿t go higher.The upper limit light isn¿t on.I think she was just impatient and not waiting long enough to connect to the ipg, since it went up one level at first.She needs to be seen in office.I don¿t think it¿s a remote issue.It¿s possible it¿s just some later healing, but there might be an issue.

• 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: 8843633
• Report Number: 3007666314-2019-00064
• Device Sequence Number: 1658590
• Product Code: MNQ
• UDI-Device Identifier: 10855728005366
• UDI-Public: 10855728005366
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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): 07/30/2019
• 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: 900-007-001
• 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: 07/29/2019
• Initial Report FDA Received Date: 07/30/2019
• 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