* 5031TK2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-11 for * 5031TK2 manufactured by Boston Scientific Corp..

Event Text Entries

[15007849] We believe that the temperature control was bad, because on the ept ablation generator the selector would not default to "temperature" , which according to ept tech support it is supposed to do each time the catheter is connected to the automatic personality module (apm). Furthermore, the generator could not be manually changed to the "temperature" selection.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 592665
• MDR Report Key: 592665
• Date Received: 2005-04-11
• Date of Report: 2005-04-11
• Date of Event: 2005-02-15
• Report Date: 2005-04-11
• Date Reported to FDA: 2005-04-11
• Date Added to Maude: 2005-04-20
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: *
• Generic Name: CARDIAC ABLATION CATHETER
• Product Code: MIK
• Date Received: 2005-04-11
• Model Number: *
• Catalog Number: 5031TK2
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 582512
• Manufacturer: BOSTON SCIENTIFIC CORP.
• Manufacturer Address: ONE BOSTON SCIENTIFIC PL. NATICK MA 01760 US

Device Sequence Number: 2

• Brand Name: CARDIAC ABLATION SYSTEM
• Generic Name: CARDIAC ABLATION RF GENERATOR
• Product Code: MIK
• Date Received: 2005-04-11
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 582513
• Manufacturer: BOSTON SCIENTIFIC
• Manufacturer Address: ONE BOSTON SCIENTIFIC PL. NATICK MA 01760 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-04-11