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