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 Number: 3007666314-2019-00064
• MDR Report Key: 8843633
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-07-30
• Date of Report: 2019-07-30
• Date of Event: 2019-07-29
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2019-07-29
• Date Added to Maude: 2019-07-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. JOEL AABERG
• Manufacturer Street: 5500 WAYZATA BLVD. SUITE 1600
• Manufacturer City: GOLDEN VALLEY MN 55416
• Manufacturer Country: US
• Manufacturer Postal: 55416
• Manufacturer Phone: 7632057970
• Manufacturer G1: INSPIRE MEDICAL SYSTEMS
• Manufacturer Street: 5500 WAYZATA BLVD. SUITE 1600
• Manufacturer City: GOLDEN VALLEY MN 55416
• Manufacturer Country: US
• Manufacturer Postal Code: 55416
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INSPIRE MODEL 3028 IPG
• Generic Name: INSPIRE MODEL 3028 IPG
• Product Code: MNQ
• Date Received: 2019-07-30
• Model Number: 3028
• Catalog Number: 900-007-001
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INSPIRE MEDICAL SYSTEMS
• Manufacturer Address: 5500 WAYZATA BLVD. SUITE 1600 GOLDEN VALLEY MN 55416 US 55416

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2019-07-30