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

Model Number 4323

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Code Available (3191)

Event Date 12/13/2017

Event Type  malfunction  

Event Description

No patient injury but the sensor lead produced abnormal waveforms.Patient continued to use therapy anyway for a while but eventually had a revision procedure to replace the sensor lead to address electrical leakage from the original lead.

Event Description

Follow up report to 3007666314-2018-00028: the "date received by manufacturer" in the initial report was 21-aug-2018.However following the submission of the initial report we have learned that a company representative was aware of the event prior to that time, specifically back on 13-dec-2018.The reason for this follow up report is to correct the "date received by manufacturer" to that of 13-dec-2018.

Event Description

Follow up report 002: previous follow up report correcting the awareness date indicated that the awareness date was dec 13, 2018 when in fact it was dec 13, 2017.The purpose of this report is to make that correction.

• Brand Name: INSPIRE SENSING LEAD
• Type of Device: PRESSURE 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: 7824466
• MDR Text Key: 118556418
• Report Number: 3007666314-2018-00028
• Device Sequence Number: 1
• Product Code: MNQ
• UDI-Device Identifier: 00855728005000
• UDI-Public: 00855728005000
• 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,Followup,Followup
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4323
• Device Catalogue Number: 900-002-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2018
• 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