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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 3024 IPG
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INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 3024 IPG Back to Search Results
Model Number 3024
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Facial Nerve Paralysis (1846); Dysphasia (2195)
Date of Event 06/01/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Capa remediation.
 
Event or Problem Description
The patient complained of lisping, right lower lip numbness, and a crooked smile at his post-op, 1-month, and 2-month appointments.The physician confirmed that the issue is now resolved.
 
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Brand Name
INSPIRE MODEL 3024 IPG
Common Device Name
INSPIRE MODEL 3024 IPG
Manufacturer (Section D)
INSPIRE MEDICAL SYSTEMS
5500 wayzata blvd.
suite 1600
golden valley MN 55416
MDR Report Key8693651
Report Number3007666314-2019-00043
Device Sequence Number2354533
Product Code MNQ
UDI-Device Identifier00855728005024
UDI-Public00855728005024
Combination Product (Y/N)Y
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P130008
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 06/11/2019
Report Date (Section F) 01/01/2005
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 Health Professional
Device Model Number3024
Device Catalogue Number900-003-015
Was the Report Sent to FDA? Yes
Date Report to Manufacturer01/10/2005
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/21/2017
Initial Report FDA Received Date06/12/2019
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 Other;
Date Report Sent to FDA01/01/2005
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