EP3 W/BATTERY (PS6100F1) NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-09-19 for EP3 W/BATTERY (PS6100F1) NA manufactured by .

MAUDE Entry Details

• Report Number: 2247064-2003-00001
• MDR Report Key: 490099
• Report Source: 07
• Date Received: 2003-09-19
• Date of Report: 2003-09-17
• Date of Event: 2003-08-19
• Date Mfgr Received: 2003-08-19
• Device Manufacturer Date: 2002-03-01
• Date Added to Maude: 2003-10-22
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: JAMES KUHN JR.
• Manufacturer Street: COOPER RUN EXECUTIVE PARK 575 RT73 N BLDG D
• Manufacturer City: WEST BERLIN NJ 08091
• Manufacturer Country: US
• Manufacturer Postal: 08091
• Manufacturer Phone: 8567538533
• Manufacturer G1: EP MEDSYSTEMS
• Manufacturer Street: COOPER RUN EXECUTIVE PARK 575 RT73 N BLDG D
• Manufacturer City: WEST BERLIN NJ 08091
• Manufacturer Country: US
• Manufacturer Postal Code: 08091
• Single Use: 3
• Remedial Action: RL
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Generic Name: EP3 STIMULATOR W/BATTERY
• Product Code: DTA
• Date Received: 2003-09-19
• Returned To Mfg: 2003-08-21
• Model Number: EP3 W/BATTERY (PS6100F1)
• Catalog Number: NA
• Lot Number: NA
• ID Number: 10-0000-4100 (BATTERY)
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 471054
• Baseline Brand Name: EP MED SYSTEM
• Baseline Generic Name: EP3 STIMULATOR W/BATTERY
• Baseline Model No: EP3 W/BATTERY (
• Baseline Catalog No: NA
• Baseline ID: 10-0000-4100 (B

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-09-19