MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-27 for EP-4 STIMULATOR SYSTEM 110V EP-4-04 manufactured by St. Jude Medical, Inc..
[131531077]
During an ablation procedure, the error message "ep4 is not responding - hardware is not responding" was displayed on the touch screen. The device was power-cycled; however, it did not pass the self test and returned to the main menu on the touch screen. The procedure was cancelled and there were no adverse patient consequences. Reconnecting the cables after the procedure resolved the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184149-2018-00211 |
| MDR Report Key | 8200499 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-27 |
| Date of Report | 2019-02-12 |
| Date of Event | 2018-11-27 |
| Date Mfgr Received | 2019-01-31 |
| Device Manufacturer Date | 2018-01-04 |
| Date Added to Maude | 2018-12-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC. |
| Manufacturer Street | ONE ST. JUDE MEDICAL DRIVE |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EP-4 STIMULATOR SYSTEM 110V |
| Generic Name | GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE |
| Product Code | JOQ |
| Date Received | 2018-12-27 |
| Model Number | EP-4-04 |
| Lot Number | 6262800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-27 |