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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 Perforation of Vessels (2135)
Date of Event 06/20/2019
Type of Reportable Event Serious Injury
Event or Problem Description
During an implant procedure, the physician hit an unexpected blood vessel during the tunneling portion of the case.The physician made an extra incision to ensure all bleeding was contained.They searched until no bleeding was observed with valsalva, then closed the incision.The patient was kept overnight for observation and the issue resolved with no hematoma.
 
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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 Key8728209
Report Number3007666314-2019-00052
Device Sequence Number2022461
Product Code MNQ
UDI-Device Identifier10855728005397
UDI-Public10855728005397
Combination Product (Y/N)Y
Initial Reporter StateMA
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 health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/24/2019
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
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/20/2019
Initial Report FDA Received Date06/24/2019
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; Required Intervention;
Date Report Sent to FDA01/01/2005
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