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

Model Number MODEL 4323

Device Problem Use of Device Problem (1670)

Patient Problem Pneumothorax (2012)

Event Date 09/21/2017

Event Type  Injury  

Manufacturer Narrative

The pneumothorax was caused by a surgical tool called a ribbon retractor.This tool is not manufactured by inspire medical systems but since it caused the pneumothorax while being used during an inspire implant procedure, specifically in preparation for placement of the inspire model 4323 sensing lead we are filing this mdr.

Event Description

During tunnelling, prior to placement of the sensor lead, physician was using a malleable ribbon retractor which is not an inspire product.The retractor was placed into the intercostal space but planed slightly below the internal intercostal fibers.A slight noise was noted and some small bubbles were observed.Corrective measures were taken to manage what appeared to be a small pneumothorax.No lung collapse or volume change was noted and once it was determined the situation was stable the sensor was placed and the case completed as normal.The patient was observed and no further complications were noted.

• Brand Name: INSPIRE
• Type of Device: SENSING LEAD
• 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: 7945364
• MDR Text Key: 123053053
• Report Number: 3007666314-2018-00043
• Device Sequence Number: 1
• Product Code: MNQ
• UDI-Device Identifier: 10855728005496
• UDI-Public: 10855728005496
• 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: Physician
• Type of Report: Initial
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MODEL 4323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention