CARDIAC ABLATION CONTROLLER EPT1000XP *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-07-14 for CARDIAC ABLATION CONTROLLER EPT1000XP * manufactured by Boston Scientific.

Event Text Entries

[426360] Small burn on patients leg near the return electrode. Technical assessment by biomed: unable to test device; not operating. Interviewed staff and learned that the ablation controller had alarmed two times during the procedure. On neither occasion did staff check electrode. Spoke to boston scientific and they stated that electrode should be placed on patient's back.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 623064
• MDR Report Key: 623064
• Date Received: 2005-07-14
• Date of Report: 2005-07-14
• Date of Event: 2005-06-28
• Report Date: 2005-07-14
• Date Reported to FDA: 2005-07-14
• Date Added to Maude: 2005-07-29
• 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
• 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 Details

• Brand Name: CARDIAC ABLATION CONTROLLER
• Generic Name: ABLATION CONTROLLER
• Product Code: MIK
• Date Received: 2005-07-14
• Model Number: EPT1000XP
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 612712
• Manufacturer: BOSTON SCIENTIFIC
• Manufacturer Address: 1 BOSTON SCIENTIFIC PL. NATICK MA 01760 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-07-14