MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2015-02-17 for NIM RESPONSE? 2.0 INTERFACE 8252200 manufactured by Medtronic Xomed, Inc..
[5355294]
It was reported that during a mastoidectomy, the system recognized the electrodes going from set-up to the monitoring screen and the connection was "normal". However, there was no response from the electrode. Follow-up attempts have been made to gather additional information with no response received. There was no injury reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[12888574]
(b)(4). A simulator, probe, and mainframe were provided by s<(>&<)>r for testing purposes. The interface, simulator and probe were connected and the mainframe turned on; boot-up sequence completed with no errors. Touchscreen responded. A monitoring mode was selected using all available channels. Each channel was stimulated in turn; no response was seen on any channel. The complaint was confirmed. The fuse was replaced in the patient interface and each channel was again stimulated. This time normal and appropriate responses were seen on all channels. The most likely cause of the reported event is misuse where the user contacted the stimulating probe with another high current device such as an electro-cautery unit. This will cause a fuse in the patient interface to blow. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[31981918]
Follow-up from the customer indicates they experienced the same connection issue with all channels of the patient interface. When the probe was used, no waveform was displayed. The case was completed without the device. The event resulted in a 30 minute delay. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[31981919]
Follow-up from the customer indicates they experienced the same connection issue with all channels of the patient interface. When the probe was used, no waveform was displayed. The case was completed without the device. The event resulted in a 30 minute delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2015-00050 |
| MDR Report Key | 4521139 |
| Report Source | 01,05,06,07 |
| Date Received | 2015-02-17 |
| Date of Report | 2015-01-23 |
| Date of Event | 2015-01-23 |
| Date Mfgr Received | 2015-02-22 |
| Device Manufacturer Date | 2004-03-05 |
| Date Added to Maude | 2015-03-20 |
| 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 | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DR NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR NORTH |
| 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 RESPONSE? 2.0 INTERFACE |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2015-02-17 |
| Returned To Mfg | 2015-02-11 |
| Model Number | 8252200 |
| Catalog Number | 8252200 |
| Lot Number | NI |
| 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 | 2015-02-17 |