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 2010-09-20 for THERAPY ABLATION CATH. 7F, 1304-7-25-L-TE8TC2 83425 NA manufactured by St Jude Medical, Irvine.
[1698598]
It was reported that during an ep procedure the user noticed some difficulties reading the temperature. Once the catheter was extracted some char on the distal electrode was observed. The tip of the catheter was clean. The catheter has been replaced with a new one and the procedure completed successfully without consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5
[8715178]
We are awaiting device return. Once we have completed out investigation, a f/u report will be submitted. Date report submitted to fda by manufacturer: 09/20/2010. Date the initial reporter provided the information to the manufacturer: (b)(4) 2010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2030404-2010-00137 |
| MDR Report Key | 1860087 |
| Report Source | 01,05,06,07 |
| Date Received | 2010-09-20 |
| Date of Report | 2010-08-25 |
| Date of Event | 2010-08-25 |
| Date Facility Aware | 2010-08-25 |
| Date Added to Maude | 2011-04-01 |
| 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 DRIVE |
| Manufacturer City | ST PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal | 55117 |
| Manufacturer Phone | 6517562000 |
| Manufacturer G1 | ST JUDE MEDICAL, IRVINE |
| Manufacturer Street | 2382 MORSE AVE. |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERAPY ABLATION CATH. 7F, 1304-7-25-L-TE8TC2 |
| Generic Name | NONE |
| Product Code | MIB |
| Date Received | 2010-09-20 |
| Model Number | 83425 |
| Catalog Number | NA |
| Lot Number | K22877 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST JUDE MEDICAL, IRVINE |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-20 |