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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 4323 RESPIRATORY SENSING LEAD
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INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 4323 RESPIRATORY SENSING LEAD Back to Search Results
Model Number 4323
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pneumothorax (2012)
Date of Event 02/12/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Pneumothorax found on chest x-ray following implant procedure.Doctor believes it was caused during tunneling.The patient had a chest tube placed and was kept in the hospital overnight.
 
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Brand Name
INSPIRE MODEL 4323 RESPIRATORY SENSING LEAD
Common Device Name
INSPIRE MODEL 4323 RESPIRATORY SENSING LEAD
Manufacturer (Section D)
INSPIRE MEDICAL SYSTEMS
5500 wayzata blvd.
suite 1600
golden valley MN 55416
MDR Report Key8346070
Report Number3007666314-2019-00015
Device Sequence Number1058043
Product Code MNQ
UDI-Device Identifier10855728005403
UDI-Public10855728005403
Combination Product (Y/N)Y
Initial Reporter StateVA
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) 02/15/2019
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 Number4323
Device Catalogue Number900-002-008
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 02/13/2019
Initial Report FDA Received Date02/15/2019
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 Required Intervention;
Date Report Sent to FDA01/01/2005
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