FREESTYLE AORTIC ROOT BIOPROSTHESIS FR995-29

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for FREESTYLE AORTIC ROOT BIOPROSTHESIS FR995-29 manufactured by Medtronic Heart Valve Division.

MAUDE Entry Details

• Report Number: 2025587-2020-00872
• MDR Report Key: 9859947
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-03-20
• Date of Report: 2020-03-20
• Date of Event: 2020-03-10
• Date Mfgr Received: 2020-03-10
• Device Manufacturer Date: 2008-07-09
• Date Added to Maude: 2020-03-20
• 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: PAULA BIXBY
• Manufacturer Street: 8200 CORAL SEA STREET NE
• Manufacturer City: MOUNDS VIEW MN 55112
• Manufacturer Country: US
• Manufacturer Postal: 55112
• Manufacturer Phone: 7635055378
• Manufacturer G1: MEDTRONIC HEART VALVE DIVISION
• Manufacturer Street: 1851 E DEERE AVE
• Manufacturer City: SANTA ANA CA 92705
• Manufacturer Country: US
• Manufacturer Postal Code: 92705
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Generic Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Product Code: LWR
• Date Received: 2020-03-20
• Model Number: FR995-29
• Catalog Number: FR995-29
• Device Expiration Date: 2013-06-18
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC HEART VALVE DIVISION
• Manufacturer Address: 1851 E DEERE AVE SANTA ANA CA 92705 US 92705

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-20