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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC. INSPIRE MODEL 4063 STIMULATION LEAD; NEUROSTIMULATION LEAD
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INSPIRE MEDICAL SYSTEMS INC. INSPIRE MODEL 4063 STIMULATION LEAD; NEUROSTIMULATION LEAD Back to Search Results
Model Number MODEL 4063
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 11/18/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device implanted and in use.
 
Event or Problem Description
Mucosal tear in floor of the mouth either happening from the blue nim probe (another manufacturers device) used to monitor geniohyoid or from nerve dissection due to challenging anatomy while implanting the model 4063 stimulation lead.The doctor placed 3 disposable stitches in the floor of the patients mouth and sent him home on antibiotics.
 
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Brand Name
INSPIRE MODEL 4063 STIMULATION LEAD
Common Device Name
NEUROSTIMULATION LEAD
Manufacturer (Section D)
INSPIRE MEDICAL SYSTEMS INC.
9700 63rd ave n
suite 200
maple grove MN 55369
MDR Report Key6139837
Report Number3007666314-2016-00013
Device Sequence Number787321
Product Code MNQ
UDI-Device Identifier00855728005017
UDI-Public00855728005017
Combination Product (Y/N)N
Initial Reporter StateNV
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 company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/01/2016
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 4063
Device Catalogue Number900-001-005
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/18/2016
Initial Report FDA Received Date12/01/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
NIM DEVICE USED TO IDENTIFY NERVE BRANCHES
Outcome Attributed to Adverse Event Required Intervention;
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