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 4 LESION NT2000? PAIN MANAGEMENT RF GENERATOR RFG-NT-2000 manufactured by St. Jude Medical, Inc..
[176647472]
One 4 lesion nt2000 rf generator was received for analysis. Visual inspection of the returned generator revealed burnt components on the upper assembly. Ac power was applied to the rf generator and the system powered on with a continuous beep confirming the reported event. The upper assembly was replaced with a good upper assembly and the issue was resolved. Based on the information provided to abbott and the investigation performed, the cause for the reported event was due to an abnormally functioning generator upper assembly.
Patient Sequence No: 1, Text Type: N, H10
[176647473]
This event is being reported based on analysis which revealed burnt components in the generator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184149-2020-00011 |
| MDR Report Key | 9638610 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2015-09-16 |
| 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 | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ST. JUDE MEDICAL, INC. |
| Manufacturer Street | ONE ST. JUDE MEDICAL DRIVE |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55117 |
| 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 | 2020-01-28 |
| Model Number | RFG-NT-2000 |
| Catalog Number | RFG-NT-2000 |
| Lot Number | 6028094 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-28 |