MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2014-02-26 for GENERATOR AQM 115V 40-402-1 manufactured by Medtronic Advanced Energy, Llc.
[4197471]
Doctor reported that the aquamantys 6. 0 device has caused extra tightness in tka cases and tightness is affecting patients' recovery process. Doctor reports tka patients are not able to get their full extension back after surgery, specifically, patients are able to flex well but not fully extend. Potential tightness due to tissue scarring in the capsule. Doctor has changed technique with use of device and previously may have been putting the knee implants in too tight so he tried putting them in loose but did not resolve the issue (which is a possible contributing factor). To resolve the issue with some patients, the doctor has had to surgically manipulate the knee to be able to get the full extension back. Patient specifics unknown.
Patient Sequence No: 1, Text Type: D, B5
[11630731]
(b)(4). Method/results/conclusion: generator still in use and facility not returning for investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103810364]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00018 |
| MDR Report Key | 3648472 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2014-02-26 |
| Date of Report | 2014-01-29 |
| Date of Event | 2014-01-29 |
| Date Mfgr Received | 2014-01-29 |
| Date Added to Maude | 2014-05-09 |
| 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 | 3 |
| Event Location | 3 |
| 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 | GENERATOR AQM 115V |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-02-26 |
| Model Number | 40-402-1 |
| Catalog Number | 40-402-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-02-26 |