4 LESION NT2000? PAIN MANAGEMENT RF GENERATOR RFG-NT-2000

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 2020-03-26 for 4 LESION NT2000? PAIN MANAGEMENT RF GENERATOR RFG-NT-2000 manufactured by St. Jude Medical, Inc..

MAUDE Entry Details

• Report Number: 2184149-2020-00038
• MDR Report Key: 9882486
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-03-26
• Date of Report: 2020-03-26
• Date of Event: 2020-02-26
• Date Mfgr Received: 2020-03-04
• Device Manufacturer Date: 2012-11-21
• Date Added to Maude: 2020-03-26
• 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: STEPHANIE O' SULLIVAN
• Manufacturer Street: 5050 NATHAN LANE NORTH
• Manufacturer City: PLYMOUTH MN 55442
• Manufacturer Country: US
• Manufacturer Postal: 55442
• Manufacturer Phone: 6517565400
• Manufacturer G1: ST. JUDE MEDICAL, INC.
• Manufacturer Street: ONE ST. JUDE MEDICAL DRIVE
• Manufacturer City: ST. PAUL MN 55117
• Manufacturer Country: US
• Manufacturer Postal Code: 55117
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 4 LESION NT2000? PAIN MANAGEMENT RF GENERATOR
• Generic Name: GENERATOR, LESION, RADIOFREQUENCY
• Product Code: GXD
• Date Received: 2020-03-26
• Model Number: RFG-NT-2000
• Catalog Number: RFG-NT-2000
• Lot Number: 7177533
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ST. JUDE MEDICAL, INC.
• Manufacturer Address: ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-03-26