MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-06-03 for RFG-3CF SYSTEM, 117 V/60 HZ RFG3CF11760 manufactured by Covidien Lp (valleylab).
[15625941]
The customer reported that following a standard nerve ablation procedure for pain, the patient's right side has motor and sensory loss below the knee. The left side ablation procedure was performed with no issues. The patient was being seen by a neurologist and rehab specialist. The customer reported they do not believe there are any issues with the generator but want to get it checked out and also do not believe covidien ablation accessories were in use.
Patient Sequence No: 1, Text Type: D, B5
[15989175]
(b) (4). (b) (4). The incident device has been received and is under evaluation. When the device evaluation is complete a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2009-00251 |
| MDR Report Key | 1443384 |
| Report Source | 05,06 |
| Date Received | 2009-06-03 |
| Date of Report | 2009-05-04 |
| Date of Event | 2009-04-01 |
| Date Mfgr Received | 2009-05-04 |
| Device Manufacturer Date | 2002-12-01 |
| Date Added to Maude | 2010-05-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIM SCHWARZ - MANAGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306245 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RFG-3CF SYSTEM, 117 V/60 HZ |
| Generic Name | RF ABLATION GENERATOR |
| Product Code | NBN |
| Date Received | 2009-06-03 |
| Returned To Mfg | 2009-05-08 |
| Catalog Number | RFG3CF11760 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP (VALLEYLAB) |
| Manufacturer Address | 5920 LONGBOW DRIVE BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-03 |