MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2010-10-26 for NAVX SURFACE ELECTRODE KIT EN0010 EN1000 manufactured by St Jude Medical, Af Div.
[1669532]
It was reported that this pt had an atrial fibrillation ablation procedure using the ensite navx system on (b)(6) 2010. When he returned for an appt following his procedure, he complained of a red itchy rash on the area where the navx patch was placed during the procedure.
Patient Sequence No: 1, Text Type: D, B5
[8918241]
The patches were not returned for eval. The cause of the reported rash could not be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184149-2010-00034 |
| MDR Report Key | 1892267 |
| Report Source | 01,05,06,07 |
| Date Received | 2010-10-26 |
| Date of Report | 2010-09-30 |
| Date of Event | 2010-09-30 |
| Date Added to Maude | 2010-11-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | SETH KERSTEN |
| Manufacturer Street | ONE ST JUDE MEDICAL DR |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal | 55117 |
| Manufacturer Phone | 6517562000 |
| Manufacturer G1 | ST. JUDE MEDICAL |
| Manufacturer Street | ST JUDE MEDICAL DR |
| 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 | NAVX SURFACE ELECTRODE KIT |
| Generic Name | NAVX |
| Product Code | ODR |
| Date Received | 2010-10-26 |
| Model Number | EN0010 |
| Catalog Number | EN1000 |
| Lot Number | NA |
| ID Number | NA |
| 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, AF DIV |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-10-26 |