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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC INSPIRE; SENSING LEAD
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INSPIRE MEDICAL SYSTEMS INC INSPIRE; SENSING LEAD Back to Search Results
Model Number 4323
Medical Device Problem Code Device Sensing Problem (2917)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/19/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Returned product analysis of the sensing lead revealed that the dip cpat insulation on the sense lead had been cut, possibly during implant procedure.This damage would be consistent with the device issues reported.
 
Event or Problem Description
Initial report was that patient required device setting adjsutments but subsequently it was made known to inspire that issues with sensing and waveforms led to two revision surgeriers, one to replace the sensing lead (b)(6) 2018), and then later (b)(6) 2018) the ipg was replaced.This resolved the issues and there was no patient injury.
 
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Brand Name
INSPIRE
Common Device Name
SENSING LEAD
Manufacturer (Section D)
INSPIRE MEDICAL SYSTEMS INC
9700 63rd ave n
suite 200
maple grove MN 55369
MDR Report Key7936254
Report Number3007666314-2018-00041
Device Sequence Number11131078
Product Code MNQ
UDI-Device Identifier10855728005496
UDI-Public10855728005496
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P130008
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number4323
Device Catalogue Number900-002-009
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/19/2018
Initial Report FDA Received Date10/04/2018
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;
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