MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-04-04 for EP-WORKMATE WM-01M-1200 manufactured by St. Jude Medical, Inc. (af-st. Paul).
[4416439]
During an atrial fibrillation ablation procedure using an ep-4 cardiac stimulator, the patient developed phrenic nerve palsy. The procedure was initiated using ensite navx for mapping and the phrenic nerve was reportedly located by pacing on the right side of the heart. The physician then changed to using ensite array for mapping. Radiofrequency ablation was being performed in the right atrium when the patient's diaphragm movement was noted to be decreased. After approximately 20 minutes, the patient appeared to recover and the physician changed back to using ensite navx where capture of cardiac tissue and the phrenic nerve was unsuccessful. It was then noted two pacing channels were selected on the ep-4 cardiac stimulator, instead of one. When one channel was deselected, pacing was then successful. Two days later, the patient complained of difficulty taking a full breath. A ct of the chest revealed the right hemidiaphragm was elevated and not responding smoothly. The patient is currently receiving pulmonary rehabilitation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184149-2014-00003 |
| MDR Report Key | 3763290 |
| Report Source | 05,07 |
| Date Received | 2014-04-04 |
| Date of Report | 2014-03-10 |
| Date of Event | 2014-03-10 |
| Date Mfgr Received | 2014-03-10 |
| Date Added to Maude | 2014-04-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DENISE JOHNSON, RN |
| Manufacturer Street | 177 EAST COUNTRY ROAD B |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal | 55117 |
| Manufacturer Phone | 6517564071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EP-WORKMATE |
| Product Code | JOQ |
| Date Received | 2014-04-04 |
| Returned To Mfg | 2014-03-26 |
| Model Number | WM-01M-1200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. (AF-ST. PAUL) |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-04-04 |