MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-03 for NIM? 2.0 MAINFRAME - PULSE 8252201 manufactured by Medtronic Xomed Inc..
[30572067]
This device is used for therapeutic purposes. (b)(6). (b)(4). The device has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[30572068]
As reported, the device stopped working halfway through the case. The case was continued without further incident. There was no report of patient injury as a result of the event.
Patient Sequence No: 1, Text Type: D, B5
[34493811]
The device was returned for evaluation at the international service depot in heerlen netherlands. Incoming inspection found the device starts up normally. Mechanical/functional testing confirmed the reported complaint as the monitor displayed a message? Warning emg monitoring is disabled?. The impedance amp board and emg board were replaced (international service depots still repair the nim 2. 0 models; however, these models are no longer serviced in the us). The device was tested to product specifications and returned to the customer. Methods - actual device evaluated. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102477806]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2015-00356 |
| MDR Report Key | 5198684 |
| Date Received | 2015-11-03 |
| Date of Report | 2015-10-06 |
| Date of Event | 2015-10-01 |
| Date Mfgr Received | 2015-12-16 |
| Device Manufacturer Date | 2008-03-03 |
| Date Added to Maude | 2015-11-03 |
| 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 | CHARLOTTE AYALA |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328372 |
| Manufacturer G1 | MEDTRONIC INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIM? 2.0 MAINFRAME - PULSE |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2015-11-03 |
| Returned To Mfg | 2015-11-05 |
| Model Number | 8252201 |
| Catalog Number | 8252201 |
| Lot Number | 54817600 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-03 |