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 2020-01-22 for 4 LESION NT2000? PAIN MANAGEMENT RF GENERATOR RFG-NT-2000 manufactured by Neurotherm, Inc.
[175868311]
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
[175868312]
During the start of the procedure, following anesthesia administration, a cancellation occurred due to an error message. The error message "communication error: controller not responding or incompatible" was displayed. The generator was power cycled but the issue was not resolved. The procedure was cancelled. There were no adverse patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002953813-2020-00004 |
| MDR Report Key | 9616160 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-22 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2013-09-09 |
| Date Added to Maude | 2020-01-22 |
| 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 | 2020-01-22 |
| Returned To Mfg | 2020-02-03 |
| Model Number | RFG-NT-2000 |
| Catalog Number | RFG-NT-2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-22 |