MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-15 for 4 LESION NT2000? PAIN MANAGEMENT RF GENERATOR RFG-NT-2000 manufactured by St. Jude Medical, Inc..
[166626975]
The results/method and conclusion codes along with investigation results will be provided in the final report. Further information regarding the event were requested but not received.
Patient Sequence No: 1, Text Type: N, H10
[166626976]
During a procedure, the probes were not exceeding the ambient temperature and there was sporadic impedance. Troubleshooting included checking the grounding pad, restarted the lesion, restarting the device, changing adaptors, changing the electrodes and ablating with only one probe at a time. The procedure was cancelled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184149-2019-00227 |
| MDR Report Key | 9330033 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-15 |
| Date of Report | 2019-11-15 |
| Date of Event | 2019-10-24 |
| Date Mfgr Received | 2019-10-24 |
| Device Manufacturer Date | 2016-02-16 |
| Date Added to Maude | 2019-11-15 |
| 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. (AF-ST. PAUL) |
| 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 | 4 LESION NT2000? PAIN MANAGEMENT RF GENERATOR |
| Generic Name | GENERATOR, LESION, RADIOFREQUENCY |
| Product Code | GXD |
| Date Received | 2019-11-15 |
| Model Number | RFG-NT-2000 |
| Catalog Number | RFG-NT-2000 |
| Lot Number | 6025253 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-11-15 |