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.
[4954752]
After a multilevel spine fusion case, where the aquamantys system was utilized, it was reported that a patient had a loss of feeling in his left 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 was still in the hospital and starting to get a tingling sensation back into his leg, but no motor skills yet. The surgeon stated that he anticipates the sensory and motor function to return to normal over 1 to 3 months. Patient is diabetic with spinal stenosis. Prior to surgery he was partially ambulatory utilizing a wheelchair about 50% of the time.
Patient Sequence No: 1, Text Type: D, B5
[11952395]
(b)(4). Evaluation method/result/conclusion: generator still in use at the facility; therefore, analysis unable to be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00062 |
| MDR Report Key | 3994179 |
| Report Source | 06,07 |
| Date Received | 2014-08-08 |
| Date of Report | 2014-07-10 |
| Date of Event | 2014-07-02 |
| Date Mfgr Received | 2014-07-10 |
| 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 |