NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CM C-1005-S

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 NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CM C-1005-S manufactured by St. Jude Medical, Inc..

MAUDE Entry Details

• Report Number: 2182269-2019-00207
• MDR Report Key: 9342160
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-11-19
• Date of Report: 2019-11-19
• Date of Event: 2019-07-22
• Date Mfgr Received: 2019-10-31
• Device Manufacturer Date: 2019-02-25
• 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: 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: 14901 DEVEAU PLACE
• Manufacturer City: MINNETONKA MN 55345
• Manufacturer Country: US
• Manufacturer Postal Code: 55345
• Single Use: 3
• Remedial Action: RC
• Previous Use Code: 3
• Removal Correction Number: FA-Q419-NM_EP-2
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CM
• Generic Name: RF CANNULA
• Product Code: GXI
• Date Received: 2019-11-19
• Model Number: C-1005-S
• Lot Number: 6865795
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ST. JUDE MEDICAL, INC.
• Manufacturer Address: 14901 DEVEAU PLACE MINNETONKA MN 55345 US 55345

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-11-19