MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC. INSPIRE MODEL 3024 IPG; IMPLANTABLE PULSE GENERATOR

Model Number 3024

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Discomfort (2330)

Event Date 05/24/2017

Event Type  malfunction  

Event Description

The patient is experiencing variation in stimulation strength.The patient also felt ipg has migrated.Is not using therapy much at home due stimulation feeling very strong at times.Device testing revealed abnormal impedances and abnormal waveforms and abnormal motion of the tongue during test telemetry mode.Instructed patient to discontinue therapy until further notice from her physician and nurse practitioner.On (b)(6), it was determined that there may be electrical leakage associated with the sensor lead and that a revision surgery would be conducted, ut has not been conducted as of yet.

Event Description

Root cause analysis determined that the issues was caused by surgical error, i.E.Cut to the insulation of the model 4323 lead during implant.

• Brand Name: INSPIRE MODEL 3024 IPG
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC.; 9700 63rd ave n; suite 200; maple grove MN 55369
• Manufacturer (Section G): INSPIRE MEDICAL SYSTEMS INC; 9700 63rd ave n; suite 200; maple grove MN 55369
• Manufacturer Contact: joel aaberg ; 9700 63rd ave n; suite 200; maple grove, MN 55369 ; 7632057970
• MDR Report Key: 6789772
• MDR Text Key: 82571144
• Report Number: 3007666314-2017-00012
• Device Sequence Number: 1
• Product Code: MNQ
• UDI-Device Identifier: 00855728005024
• UDI-Public: 00855728005024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3024
• Device Catalogue Number: 900-003-015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention