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 2020-02-28 for 3 LESION NT1100? PAIN MANAGEMENT RF GENERATOR RFG-NT-1100 manufactured by Neurotherm, Inc.
[181617809]
The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[181617810]
The generator screen went black and eventually rebooted to the correct screen. In addition, the lesion graphical display stopped proceeding after a few seconds but the lesion time continue and temperature continued to display, and the impedance would sometimes drop to zero. Rebooting the generator did not resolve the issue. The generator had the same undiagnosed issue for roughly a year. The dates of the procedures are unknown. Approximately six procedures were cancelled due to the issue. Additional information is not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002953813-2020-00008 |
| MDR Report Key | 9769003 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-28 |
| Date of Report | 2020-03-11 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-02-28 |
| 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 | 3 LESION NT1100? PAIN MANAGEMENT RF GENERATOR |
| Generic Name | GENERATOR, LESION, RADIOFREQUENCY |
| Product Code | GXD |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2020-03-03 |
| Model Number | RFG-NT-1100 |
| Catalog Number | RFG-NT-1100 |
| 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. Hospitalization | 2020-02-28 |