* 6210BTK NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-02-10 for * 6210BTK NA manufactured by Medtronic Inc., Cardiac Rhythm Management Division.

MAUDE Entry Details

• Report Number: 2182208-2002-00204
• MDR Report Key: 831612
• Report Source: 05
• Date Received: 2005-02-10
• Date of Event: 2002-02-05
• Date Facility Aware: 2002-02-05
• Date Mfgr Received: 2002-02-05
• Device Manufacturer Date: 2001-05-01
• Date Added to Maude: 2007-03-29
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Removal Correction Number: NI
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: PERMANENT LEAD INTRODUCER
• Product Code: DTF
• Date Received: 2005-02-10
• Model Number: 6210BTK
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: 9 MO
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 818953
• Manufacturer: MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT DIVISION
• Manufacturer Address: RICE CREEK CENTER 7000 CENTRAL AVE., NE / T279 MINNEAPOLIS MN 554323576 US
• Baseline Brand Name: SOLO TRAK KR
• Baseline Generic Name: PERMANENT LEAD INTRODUCER
• Baseline Model No: 6210BTK
• Baseline Catalog No: NA
• Baseline ID: NA
• Baseline Device Family: PERMANENT LEAD INTRODUCER
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 24
• Baseline PMA Flag: Y
• Premarket Approval: K9513
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2005-02-10