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 2020-01-28 for 3 LESION NT1100? PAIN MANAGEMENT RF GENERATOR RFG-NT-1100 manufactured by Neurotherm, Inc.
[181618527]
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported sparking was attributed to the use environment. 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.
Patient Sequence No: 1, Text Type: N, H10
[181618528]
The generator had water damage due to flooding and ports 2 and 3 would not function. During functional testing, the impedance in port 2 was 1400 ohms and port 3 would not display impedance. Additionally, an "unsafe probe" error message occurred for both ports. When testing the lesion, visible sparking was observed on the grounding pad at the site of probe 3. There was no patient involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002953813-2020-00005 |
| MDR Report Key | 9636276 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2010-05-05 |
| Date Added to Maude | 2020-01-28 |
| 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 | 2020-01-28 |
| Model Number | RFG-NT-1100 |
| Catalog Number | RFG-NT-1100 |
| 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 | 2020-01-28 |