PACEL BIPOLAR PACING CATHETER 401769

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 2019-10-31 for PACEL BIPOLAR PACING CATHETER 401769 manufactured by St. Jude Medical.

MAUDE Entry Details

• Report Number: 2182269-2019-00191
• MDR Report Key: 9259980
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-10-31
• Date of Report: 2019-11-27
• Date of Event: 2019-10-01
• Date Mfgr Received: 2019-11-14
• Device Manufacturer Date: 2019-05-16
• Date Added to Maude: 2019-10-31
• 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 (CVD-MINNETONKA)
• Manufacturer Street: 14901 DEVEAU PLACE
• Manufacturer City: MINNETONKA MN 553452126
• Manufacturer Country: US
• Manufacturer Postal Code: 553452126
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PACEL BIPOLAR PACING CATHETER
• Generic Name: ELECTRODE, PACEMAKER, TEMPORARY
• Product Code: LDF
• Date Received: 2019-10-31
• Model Number: 401769
• Catalog Number: 401769
• Lot Number: 7000868
• 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: 14901 DEVEAU PLACE MINNETONKA MN 553452126 US 553452126

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2019-10-31