ST. JUDE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-29 for ST. JUDE * manufactured by St. Jude.

Event Text Entries

[318840] Pt had a defective anastamosis clip implanted during coronary artery by-pass and saphenous vein graft, using the "one-shot proximal device" per the or report.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1030004
• MDR Report Key: 493840
• Date Received: 2003-10-29
• Date of Report: 2003-10-29
• Date of Event: 2003-10-15
• Date Added to Maude: 2003-11-07
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ST. JUDE
• Generic Name: ONE SHOT
• Product Code: DSS
• Date Received: 2003-10-29
• Returned To Mfg: 2003-10-15
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 482548
• Manufacturer: ST. JUDE
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-10-29