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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC. INSPIRE UPPER AIRWAY STIMULATION; IMPLANTABLE PULSE GENERATOR
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INSPIRE MEDICAL SYSTEMS INC. INSPIRE UPPER AIRWAY STIMULATION; IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number MODEL 3024
Health Effect - Clinical Code Discomfort (2330)
Date of Event 07/13/2017
Type of Reportable Event Serious Injury
Event or Problem Description
Patient has had difficulty with swallowing and speaking.Device was not used for a period of time to allow the patient to heal from implant.Issues resolved for a time but then returned a while after the device was reactivated.Physician is having the patient leave the device off for now to allow the patient more time to heal from implant.
 
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Brand Name
INSPIRE UPPER AIRWAY STIMULATION
Common Device Name
IMPLANTABLE PULSE GENERATOR
Manufacturer (Section D)
INSPIRE MEDICAL SYSTEMS INC.
9700 63rd ave n
suite 200
maple grove MN 55369
MDR Report Key6790029
Report Number3007666314-2017-00013
Device Sequence Number13916438
Product Code MNQ
UDI-Device Identifier00855728005055
UDI-Public00855728005055
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P130008
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Physician
Device Model NumberMODEL 3024
Device Catalogue Number900-003-015
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/13/2017
Initial Report FDA Received Date08/11/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Death; Required Intervention;
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