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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 3028 IPG
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INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 3028 IPG Back to Search Results
Model Number 3028
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Hematoma (1884)
Date of Event 02/18/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Capa remediation.
 
Event or Problem Description
The patient called the clinic on (b)(6) 2018 with complaints of neck swelling and difficulty swallowing.The physician prescribed a steroid (medrol dose pack) over the phone.The patient called their physician on (b)(6) 2018 with no resolution and came to the clinic.There they were evaluated by a nurse practitioner and found to have a neck hematoma.The patient was started on antibiotics to prevent infection.At post op visit on (b)(6) 2018 issue was resolved.
 
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Brand Name
INSPIRE MODEL 3028 IPG
Common Device Name
INSPIRE MODEL 3028 IPG
Manufacturer (Section D)
INSPIRE MEDICAL SYSTEMS
5500 wayzata blvd.
suite 1600
golden valley MN 55416
MDR Report Key8688903
Report Number3007666314-2019-00040
Device Sequence Number14040805
Product Code MNQ
UDI-Device Identifier10855728005465
UDI-Public10855728005465
Combination Product (Y/N)Y
Initial Reporter StateAL
Initial Reporter CountryUS
PMA/510(K) Number
P130008
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/11/2019
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 Number3028
Device Catalogue Number900-007-003
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 03/21/2018
Initial Report FDA Received Date06/11/2019
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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