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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 Positioning Failure (1158)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 02/05/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Planned revision surgery for stimulation lead which is too superficial to the surface of the skin.The physician would like to remove the lead and re-tunnel it deeper.
 
Event or Problem Description
Scheduled revision referenced in the initial report was completed (b)(6) 2019 without issues resolving the initial complaint.
 
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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 Key8337038
Report Number3007666314-2019-00011
Device Sequence Number2357568
Product Code MNQ
UDI-Device Identifier10855728005397
UDI-Public10855728005397
Combination Product (Y/N)Y
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P130008
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/13/2019
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 Number4063
Device Catalogue Number900-001-008
Was the Report Sent to FDA? Yes
Date Report to Manufacturer01/10/2005
Initial Date Received by Manufacturer 02/04/2019
Supplement Date Received by Manufacturer01/14/2005
Initial Report FDA Received Date02/13/2019
Supplement Report FDA Received Date06/13/2019
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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