MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-08-08 for AQUAMANTYS GENERATOR 40-402-1 manufactured by Medtronic Advanced Energy, Llc.
[16780510]
After a micro discectomy spine case, where the aquamantys system was utilized, it was reported that a patient had a loss of feeling in his one leg below the knee. Patient was taken back into surgery two days later for a decompression procedure. At the time of the reported incident the patient did not have feeling in his leg back yet, but the surgeon stated that he anticipates the sensory and motor function to return to normal over 1 to 3 months.
Patient Sequence No: 1, Text Type: D, B5
[17003240]
Product event # (b)(4) evaluation method/result/conclusion: generator still in use; therefore, analysis unable to be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00063 |
| MDR Report Key | 3994159 |
| Report Source | 06,07 |
| Date Received | 2014-08-08 |
| Date of Report | 2014-07-11 |
| Date of Event | 2014-07-08 |
| Date Mfgr Received | 2014-07-11 |
| Date Added to Maude | 2014-08-11 |
| 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 | KAYLEE BOISVERT |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal | 03801 |
| Manufacturer Phone | 6038426234 |
| Manufacturer G1 | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUAMANTYS GENERATOR |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-08-08 |
| Model Number | 40-402-1 |
| Catalog Number | 40-402-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-08 |