MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-30 for EP-WORKMATE? AND WORKMATE? CLARIS? EP-4? TOUCHSCREEN COMPUTER H21911 manufactured by St. Jude Medical, Inc..
[134456333]
During an accessory pathway ablation procedure, the stimulator displayed the error message? Ep-4 stimulator hardware is not connected? And the procedure was cancelled. Only the main screen displayed on the touchscreen and it was not possible to change the different stimulation protocols so the procedure was rescheduled. There were no adverse consequences to the patient due to the cancellation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184149-2019-00013 |
| MDR Report Key | 8288488 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-30 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-01-09 |
| Date Mfgr Received | 2019-02-27 |
| Device Manufacturer Date | 2017-05-31 |
| Date Added to Maude | 2019-01-30 |
| 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-WORKMATE? AND WORKMATE? CLARIS? EP-4? TOUCHSCREEN COMPUTER |
| Generic Name | GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE |
| Product Code | JOQ |
| Date Received | 2019-01-30 |
| Returned To Mfg | 2019-02-14 |
| Model Number | H21911 |
| Catalog Number | H21911 |
| Lot Number | 5995875 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-30 |