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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
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 06/11/2020
Event Type  Injury  
Event Description
Patient reported right side ear pain and pain in the back of her head following inspire implant surgery.Patient reported having a nerve block procedure to remedy pain at the back of her head but ear pain persists.Patient has not been seen by inspire physician since the onset of pain due to covid.
 
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Brand Name
INSPIRE MODEL 3028 IPG
Type of Device
INSPIRE MODEL 3028 IPG
Manufacturer (Section D)
INSPIRE MEDICAL SYSTEMS
5500 wayzata blvd.
suite 1600
golden valley MN 55416
Manufacturer (Section G)
INSPIRE MEDICAL SYSTEMS
5500 wayzata blvd.
suite 1600
golden valley MN 55416
Manufacturer Contact
joel aaberg
5500 wayzata blvd.
suite 1600
golden valley, MN 55416
7632057970
MDR Report Key10261474
MDR Text Key198528413
Report Number3007666314-2020-00028
Device Sequence Number1
Product Code MNQ
UDI-Device Identifier10855728005656
UDI-Public10855728005656
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P130008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Physician
Type of Report Initial
Report Date 01/01/2005,06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number3028
Device Catalogue Number900-007-008
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received06/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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