AMPERE? RF ABLATION GENERATOR H700488

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-02 for AMPERE? RF ABLATION GENERATOR H700488 manufactured by St. Jude Medical, Inc..

MAUDE Entry Details

• Report Number: 2184149-2020-00020
• MDR Report Key: 9774877
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-03-02
• Date of Report: 2020-03-02
• Date of Event: 2020-02-05
• Date Mfgr Received: 2020-02-06
• Device Manufacturer Date: 2019-04-29
• Date Added to Maude: 2020-03-02
• 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. (AF-ST. PAUL)
• 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: AMPERE? RF ABLATION GENERATOR
• Generic Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Product Code: GXD
• Date Received: 2020-03-02
• Model Number: H700488
• Catalog Number: H700488
• Lot Number: 6955465
• 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: ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-03-02