INSPIRE MODEL 3028 IPG 900-007-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-07-30 for INSPIRE MODEL 3028 IPG 900-007-001 manufactured by Inspire Medical Systems.

MAUDE Entry Details

Report Number3007666314-2019-00064
MDR Report Key8843633
Report SourceHEALTH PROFESSIONAL
Date Received2019-07-30
Date of Report2019-07-30
Date of Event2019-07-29
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2019-07-29
Date Added to Maude2019-07-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JOEL AABERG
Manufacturer Street5500 WAYZATA BLVD. SUITE 1600
Manufacturer CityGOLDEN VALLEY MN 55416
Manufacturer CountryUS
Manufacturer Postal55416
Manufacturer Phone7632057970
Manufacturer G1INSPIRE MEDICAL SYSTEMS
Manufacturer Street5500 WAYZATA BLVD. SUITE 1600
Manufacturer CityGOLDEN VALLEY MN 55416
Manufacturer CountryUS
Manufacturer Postal Code55416
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINSPIRE MODEL 3028 IPG
Generic NameINSPIRE MODEL 3028 IPG
Product CodeMNQ
Date Received2019-07-30
Model Number3028
Catalog Number900-007-001
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINSPIRE MEDICAL SYSTEMS
Manufacturer Address5500 WAYZATA BLVD. SUITE 1600 GOLDEN VALLEY MN 55416 US 55416


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-07-30

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