ATRICURE SYNERGY ABLATION SYSTEM OLL2 A000362

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 2019-11-19 for ATRICURE SYNERGY ABLATION SYSTEM OLL2 A000362 manufactured by Atricure, Inc..

MAUDE Entry Details

• Report Number: 3011706110-2019-00055
• MDR Report Key: 9343705
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-11-19
• Date of Report: 2019-11-19
• Date of Event: 2019-10-21
• Date Mfgr Received: 2019-10-21
• Device Manufacturer Date: 2019-07-17
• Date Added to Maude: 2019-11-19
• 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. JOHN EHLERT
• Manufacturer Street: 7555 INNOVATION WAY
• Manufacturer City: MASON OH 45040
• Manufacturer Country: US
• Manufacturer Postal: 45040
• Manufacturer Phone: 5136448220
• Manufacturer G1: ATRICURE, INC.
• Manufacturer Street: 7555 INNOVATION WAY
• Manufacturer City: MASON OH 45040
• Manufacturer Country: US
• Manufacturer Postal Code: 45040
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ATRICURE SYNERGY ABLATION SYSTEM
• Generic Name: ATRICURE SYNERGY ABLATION SYSTEM
• Product Code: OCM
• Date Received: 2019-11-19
• Returned To Mfg: 2019-10-29
• Model Number: OLL2
• Catalog Number: A000362
• Lot Number: 95175
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ATRICURE, INC.
• Manufacturer Address: 7555 INNOVATION WAY MASON OH 45040 US 45040

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	2019-11-19