MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-30 for 4 LESION NT2000? PAIN MANAGEMENT RF GENERATOR RFG-NT-2000 manufactured by Neurotherm, Inc.
[181617310]
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.?
Patient Sequence No: 1, Text Type: N, H10
[181617311]
During a pulsed radiofrequency nerve block procedure, the generator shut down and the procedure was cancelled. When attempting to reboot, the generator would not complete the boot up sequence and would continue to shut down. The procedure was rescheduled for a later date. There were no adverse consequences to the patient due to the cancellation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002953813-2020-00006 |
| MDR Report Key | 9646702 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-01-30 |
| 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 | NEUROTHERM, INC |
| Manufacturer Street | 600 RESEARCH DRIVE STE 1 |
| Manufacturer City | WILMINGTON MA 01887 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01887 |
| 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 | 2020-01-30 |
| Model Number | RFG-NT-2000 |
| Catalog Number | RFG-NT-2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUROTHERM, INC |
| Manufacturer Address | 600 RESEARCH DRIVE STE 1 WILMINGTON MA 01887 US 01887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-30 |