MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC. INSPIRE IMPLANTABLE PULSE GENERATOR

Model Number 3028

Device Problems Electrical /Electronic Property Problem (1198); No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2018

Event Type  malfunction  

Event Description

No injury but patient experienced variation in stimulation strength for over a month and then contacted his physician to have his device assessed.A device check revealed abnormal impedances and abnormal sensor waveforms.The issue resulted in discontinued therapy as a precaution and it may require clinician intervention to resolve.Possible device malfunction.

Event Description

Follow up report: variation in stimulation strength was due to cuts in the sensor leads insulation.There was fluid ingress in the lead indicating that the cuts occurred during implant.The patient's sensor lead needed to be replaced.

• Brand Name: INSPIRE IMPLANTABLE PULSE GENERATOR
• 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: 7762310
• MDR Text Key: 116618355
• Report Number: 3007666314-2018-00020
• Device Sequence Number: 1
• Product Code: MNQ
• UDI-Device Identifier: 10855728005465
• UDI-Public: 10855728005465
• 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
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3028
• Device Catalogue Number: 900-007-003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention