CRYOFLEX SURGICAL ABLATION PROBE 60SF2

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 2019-06-13 for CRYOFLEX SURGICAL ABLATION PROBE 60SF2 manufactured by Medtronic, Inc..

MAUDE Entry Details

• Report Number: 3008592544-2019-00021
• MDR Report Key: 8695050
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-06-13
• Date of Report: 2019-09-12
• Date of Event: 2019-05-23
• Date Mfgr Received: 2019-08-22
• Device Manufacturer Date: 2019-01-28
• Date Added to Maude: 2019-06-13
• 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, INC.
• Manufacturer Street: 3800 ANNAPOLIS LANE
• Manufacturer City: MINNEAPOLIS MN 55447
• Manufacturer Country: US
• Manufacturer Postal Code: 55447
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CRYOFLEX SURGICAL ABLATION PROBE
• Generic Name: SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
• Product Code: OCL
• Date Received: 2019-06-13
• Returned To Mfg: 2019-06-26
• Model Number: 60SF2
• Catalog Number: 60SF2
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC, INC.
• Manufacturer Address: 3800 ANNAPOLIS LANE MINNEAPOLIS MN 55447 US 55447

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-06-13