MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC. INSPIRE SLEEP REMOTE; PATIENT PROGRAMMER

Model Number 3032

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Discomfort (2330)

Event Date 02/11/2015

Event Type  malfunction  

Event Description

Pt was in the ide pivotal study for the inspire upper airway stimulation system.Recently he called his physician and stated that he was having trouble with his pt remote, specifically the pt was unable to turn off his therapy so the stimulation continued to engage the tongue protrusion muscles.The pt was experiencing discomfort so rather than waiting for the therapy to time out automatically he went to the clinic where his physician turned off the therapy using his programmer.The pt stated he had mild discomfort after having the therapy off but no other intervention was needed and the pt returned home.

• Brand Name: INSPIRE SLEEP REMOTE
• Type of Device: PATIENT PROGRAMMER
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC.; maple grove MN
• Manufacturer Contact: joel aaberg ; 9700 63rd ave n ste 200; maple grove, MN 55369 ; 7632057972
• MDR Report Key: 4658043
• MDR Text Key: 5602815
• Report Number: 3007666314-2015-00001
• Device Sequence Number: 1
• Product Code: MNQ
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2009
• Is the Device Single Use?: 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
• Patient Age: 53 YR
• Patient Weight: 93