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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
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INSPIRE MEDICAL SYSTEMS INC. INSPIRE MODEL 4063 STIMULATION LEAD Back to Search Results
Model Number 4063
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 09/13/2018
Type of Reportable Event Serious Injury
Event or Problem Description
No device malfunction but patient had a surgery to replace stimulation lead due to a post operative infection.This was a clinical study patient being followed with in a post approval study where the adverse event was first made know to the manufacturer on (b)(6) 2017.Parallel reporting requirement as a commercial patient was initially missed until recently.
 
Event or Problem Description
Follow up report: patient had complete system explant due to infection.Infection was not sterility related but rather caused by patient nicking his neck incision.Infection has resolved.
 
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Brand Name
INSPIRE MODEL 4063 STIMULATION LEAD
Common Device Name
STIMULATION LEAD
Manufacturer (Section D)
INSPIRE MEDICAL SYSTEMS INC.
9700 63rd ave n
suite 200
maple grove MN 55369
MDR Report Key7327475
Report Number3007666314-2018-00005
Device Sequence Number151145
Product Code MNQ
UDI-Device Identifier00855728005017
UDI-Public00855728005017
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P130008
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/18/2013
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 Number4063
Device Catalogue Number900-001-005
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 08/08/2017
Supplement Date Received by Manufacturer08/08/2017
Initial Report FDA Received Date03/09/2018
Supplement Report FDA Received Date09/18/2018
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 Required Intervention;
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