MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,company represent report with the FDA on 2015-02-05 for NIM? ELECTRODES EMG 8227410 manufactured by Medtronic Xomed Inc..
[20066236]
It was reported? During the facial nerve decompression surgery using the paired electrodes, the muscle had a response but it was not shown in the nim. The procedure was reportedly continued without taking any action for this incident, and completed with no delay or adverse effect.? Follow-up communication obtained additional information: it was noted that the issue may have been related to how the electrodes were placed but the doctor believes it is related to a problem with the 2 channel electrodes. There was no patient impact or injury reported.
Patient Sequence No: 1, Text Type: D, B5
[20254243]
(b)(4). This device is used for therapeutic purposes. (b)(4), nim response 2. 0 mainframe lot/serial # unknown. (b)(4): the device has been received and product analysis is anticipated but not yet begun. Method? No testing methods performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[35030710]
The device was returned and evaluated by a quality engineer. Received 1 sample(s), part number 8227410. Equipment used: microscope (zeiss stemi 2000c between 0, 65 to 5, 0 magnification settings), multimeter. Observations: when compared to the assembly drawing for paired subdermal electrode drawing: end to end resistance for each side of the paired electrodes shall be <(><<)>2. 0ohms and infinite ohms between needle tips [no short circuit]. All electrodes passed electrical testing. The information indicates an in specification condition for the returned electrodes. There was no damage to the wires or connectors which would have resulted in the reported malfunction. These electrodes are a supplied material assembly and no fault was found as it relates to the complaint therefore manufacturing and supplier have been ruled out as a potential causes. Based on the product analysis findings the underlying cause of the reported failure could not be confirmed; however, it is likely the result of use error related to the placement/location of the electrodes on the patient. Method? Actual device evaluated; electrical evaluation; visual inspection; microscopic inspection. Results? No failure detected. Conclusion? No failure detected, device operated within specification; operational context caused or contributed to event.
Patient Sequence No: 1, Text Type: N, H10
[101905208]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2015-00028 |
| MDR Report Key | 4488170 |
| Report Source | 01,05,06,07,COMPANY REPRESENT |
| Date Received | 2015-02-05 |
| Date of Report | 2015-01-14 |
| Date of Event | 2015-01-14 |
| Date Mfgr Received | 2015-02-10 |
| Date Added to Maude | 2015-03-10 |
| 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 XOMED, 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? ELECTRODES EMG |
| Generic Name | ELECTRODE, NEEDLE |
| Product Code | GXZ |
| Date Received | 2015-02-05 |
| Returned To Mfg | 2015-01-22 |
| Model Number | 8227410 |
| Catalog Number | 8227410 |
| 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 | 2015-02-05 |