MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-31 for EP STIMULATOR 1004799 manufactured by St. Jude.
[4326435]
Using the ep med system to pace before radiofrequency ablation to assess phrenic nerve. Appeared not to have capture of phrenic nerve stimulation, therefore, radiofrequency ablation turned on. Later found phrenic nerve damage via fluoroscopy. Pt initially with hiccup symptoms post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5035431 |
| MDR Report Key | 3724175 |
| Date Received | 2014-03-31 |
| Date of Report | 2014-03-28 |
| Date of Event | 2014-03-10 |
| Date Added to Maude | 2014-04-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EP STIMULATOR |
| Generic Name | EP STIMULATOR |
| Product Code | JOQ |
| Date Received | 2014-03-31 |
| Model Number | 1004799 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-31 |