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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD
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INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD Back to Search Results
Model Number 4340
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Skin Irritation (2076)
Date of Event 02/05/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The patient presented to the physician's office for surgical follow up with a rash at sense lead incision site.Patient reports rash began on (b)(6) 2019.Consultation with dermatologist suggests classic contact dermatitis from either betadine or ioban.
 
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Brand Name
INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD
Common Device Name
INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD
Manufacturer (Section D)
INSPIRE MEDICAL SYSTEMS
5500 wayzata blvd.
suite 1600
golden valley MN 55416
MDR Report Key8337375
Report Number3007666314-2019-00012
Device Sequence Number53689
Product Code MNQ
UDI-Device Identifier10855728005458
UDI-Public10855728005458
Combination Product (Y/N)Y
Initial Reporter StateGA
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) 02/13/2019
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 Number4340
Device Catalogue Number900-009-001
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 02/06/2019
Initial Report FDA Received Date02/13/2019
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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