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