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 2020-02-04 for 3 LESION NT1100? PAIN MANAGEMENT RF GENERATOR RFG-NT-1100 manufactured by Neurotherm, Inc.
[181617052]
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
[181617053]
During a procedure, the generator was switching off and there was a clinically significant delay. There were no patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002953813-2020-00007 |
| MDR Report Key | 9667786 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-02-04 |
| 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 | 2020-02-04 |
| Model Number | RFG-NT-1100 |
| Catalog Number | RFG-NT-1100 |
| Lot Number | 11998-12 |
| 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 | 2020-02-04 |