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 2020-01-29 for 3 LESION NT1100? PAIN MANAGEMENT RF GENERATOR RFG-NT-1100 manufactured by St. Jude Medical, Inc..
[176755056]
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Patient Sequence No: 1, Text Type: N, H10
[176755057]
During a simplicity procedure, the device did not reach the expected temperature and the procedure was cancelled. A single monopolar lesion was performed and then the patient was given a steroid injection instead of the procedure. The procedure will be rescheduled within the next 28 days.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2184149-2020-00012 |
MDR Report Key | 9641146 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2020-01-29 |
Date of Report | 2020-03-17 |
Date of Event | 2020-01-20 |
Date Mfgr Received | 2020-03-12 |
Device Manufacturer Date | 2008-05-21 |
Date Added to Maude | 2020-01-29 |
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 |
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 | 3 LESION NT1100? PAIN MANAGEMENT RF GENERATOR |
Generic Name | GENERATOR, LESION, RADIOFREQUENCY |
Product Code | GXD |
Date Received | 2020-01-29 |
Returned To Mfg | 2020-01-31 |
Model Number | RFG-NT-1100 |
Catalog Number | RFG-NT-1100 |
Lot Number | 11170-08 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | R |
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 | 2020-01-29 |