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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 4063 STIMULATION LEAD
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INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 4063 STIMULATION LEAD Back to Search Results
Model Number 4063
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Nerve Damage (1979)
Date of Event 05/29/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The patient is experiencing mild marginal mandibular nerve weakness.At 6 month postop follow up appointment, his nerve function had improved about 50% but had not entirely resolved.The physician believes it is likely he will have some residual deficit.Follow up check is planned at 12 months postop.
 
Event or Problem Description
Patient follow up indicated that the issue is not completely resolved but the patient is doing fine and close to normal overall and likely as good as expected.
 
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Brand Name
INSPIRE MODEL 4063 STIMULATION LEAD
Common Device Name
INSPIRE MODEL 4063 STIMULATION LEAD
Manufacturer (Section D)
INSPIRE MEDICAL SYSTEMS
5500 wayzata blvd.
suite 1600
golden valley MN 55416
MDR Report Key9282080
Report Number3007666314-2019-00087
Device Sequence Number11308690
Product Code MNQ
UDI-Device Identifier10855728005397
UDI-Public10855728005397
Combination Product (Y/N)Y
Initial Reporter CountryUS
PMA/510(K) Number
P130008
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date (Section B) 11/19/2020
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 Number4063
Device Catalogue Number900-001-008
Was the Report Sent to FDA? Yes
Date Report to Manufacturer01/10/2005
Initial Date Received by Manufacturer 10/08/2019
Supplement Date Received by Manufacturer10/08/2019
Initial Report FDA Received Date11/05/2019
Supplement Report FDA Received Date11/20/2020
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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