TRANSSEPTAL NEEDLE, BRK SERIES

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 2019-10-02 for TRANSSEPTAL NEEDLE, BRK SERIES manufactured by St. Jude Medical.

MAUDE Entry Details

• Report Number: 3008452825-2019-00495
• MDR Report Key: 9144767
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-10-02
• Date of Report: 2019-10-26
• Date of Event: 2019-08-30
• Date Mfgr Received: 2019-10-09
• Date Added to Maude: 2019-10-02
• 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, COSTA RICA LTDA (AFD)
• Manufacturer Street: PARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL
• Manufacturer City: ALAJUELA, COSTA RICA 1897-4050
• Manufacturer Country: CS
• Manufacturer Postal Code: 1897-4050
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Generic Name: TRANSSEPTAL NEEDLE
• Product Code: DRC
• Date Received: 2019-10-02
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ST. JUDE MEDICAL
• Manufacturer Address: PARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL ALAJUELA, COSTA RICA 1897-4050 CS 1897-4050

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-10-02