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 2020-03-10 for 4 LESION NT2000? PAIN MANAGEMENT RF GENERATOR RFG-NT-2000 manufactured by Neurotherm, Inc.
[187167478]
One 4 lesion nt2000? Pain management rf generator was received for analysis. Visual inspection revealed the input, output connectors and controls appeared to be free of physical damage. A damaged power entry module was observed. When the generator was powered on, an error message was observed accompanied with loud crackling sound confirming the field reported event. Further investigation revealed the generator had an intermittent stimulation board. The stimulation board was replaced temporarily with a known good stimulation board. The reported event was resolved. However, when the original stimulation board was re-installed the issue was not observed. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The review determined the process was performed and completed in accordance with abbott specifications and procedures. Based on the information provided to abbott and the investigation performed, the cause for the reported event was due to an intermittent stimulation board.
Patient Sequence No: 1, Text Type: N, H10
[187167479]
During the procedure, the generator made cackling sound upon boot up. The procedure was cancelled and rescheduled for another day. There were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002953813-2020-00010 |
| MDR Report Key | 9811355 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2014-06-06 |
| Date Added to Maude | 2020-03-10 |
| 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 | 2020-03-10 |
| Returned To Mfg | 2020-03-03 |
| Model Number | RFG-NT-2000 |
| Catalog Number | RFG-NT-2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-10 |