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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 Migration or Expulsion of Device (1395)
Health Effect - Clinical Code Erosion (1750)
Date of Event 12/07/2020
Type of Reportable Event Serious Injury
Event or Problem Description
Patient presented to the physician with a lump at the sense lead incision site.Patient received ct scan which showed the sense lead eroding into the pleural space.The physician surgically removed the sensor, which was in a thick fibrotic capsule.This resolved the issue and another sensor was implanted.
 
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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 Key11127603
Report Number3007666314-2021-00001
Device Sequence Number10971976
Product Code MNQ
UDI-Device Identifier00855728005192
UDI-Public00855728005192
Combination Product (Y/N)Y
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P130008
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/06/2021
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 Number900-002-007
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/06/2021
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;
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