EP MED SYSTEM PS6100F1 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-08 for EP MED SYSTEM PS6100F1 * manufactured by Ep Med System.

Event Text Entries

[17108523] In ep lab for av node ablation and permanent pacemaker insertion. The battery in the pacing unit failed. The pt's heartrate was 30. No warning signs of "low battery" was seen by any of the staff. It took about 2 minutes to change battery. No harm to pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 482168
• MDR Report Key: 482168
• Date Received: 2003-09-08
• Date of Report: 2003-08-26
• Date of Event: 2003-08-19
• Date Facility Aware: 2003-08-19
• Report Date: 2003-08-26
• Date Reported to FDA: 2003-08-26
• Date Reported to Mfgr: 2003-08-26
• Date Added to Maude: 2003-09-10
• 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 Details

• Brand Name: EP MED SYSTEM
• Generic Name: PACER SONIC
• Product Code: DTA
• Date Received: 2003-09-08
• Model Number: PS6100F1
• Catalog Number: *
• Lot Number: *
• ID Number: 10-0000-4100
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 471054
• Manufacturer: EP MED SYSTEM
• Manufacturer Address: 575 RT 73 NORTH, BLDG D COOPER RUN EXECUTIVE PARK WEST BERLIN NJ 080919293 US
• 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	1. Required No Informationntervention	2003-09-08