MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-02-13 for NIM? EMG ELECTRODE 8227411 manufactured by Medtronic Xomed Inc..
[67323729]
Concomitant products: 8225101? Probe, 5pk std prass flush tip; lot number? 0211358452; manufacture date? June 1, 2016; used by date? May 30, 2024; udi? (b)(4); 510k number - k934426. The device has been received by medtronic. The product analysis has not yet been completed.
Patient Sequence No: 1, Text Type: N, H10
[67323730]
It was reported that during a parotidectomy, the electrode and probe could not detect nerves. There was no surgery delay. The patient? S nerves functioned well after surgery.
Patient Sequence No: 1, Text Type: D, B5
[71012364]
(b)(4). (paired 4-channel set electrodes): the product analysis indicates that one unsealed sample was received. Visually, there was no damage or anomalies in the construction of the device(s) that would have resulted in the reported event. The paired subdermal electrodes shall exhibit continuity from needle tip to connecting pin with a measurement less than 2. 0ohms [and shall exhibit infinity between needles and connectors]. The blue paired measured 1. 7ohms / 1. 7ohms, the red paired measured 1. 6ohms / 1. 6ohms, the purple paired measured 1. 7ohms / 1. 7ohms, and the orange paired measured 1. 6ohms / 1. 6ohms. All electrodes were infinite between poles and no out of specification condition was identified. The red/white and green electrodes end to end ohms resistance shall be less than 2. 5 ohms. The actual measurements for the red/white was 0. 8 ohms. The actual measurements for the green was 0. 8 ohms, indicating an in specification condition. This is a supplied material assembly with no out of specification condition, therefore manufacturing and supplier have been ruled out as likely causes. (b)(4) (std prass flush tip probe): the product analysis indicates that one unsealed sample was received. Visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event. The tip fit securely in the handle. The probe was plugged into a nim system using 1. 0 ma stimulating current and 100uv threshold. When stimulating, the system returned 1. 02 ma and a waveform / tone over 200uv. There was no evidence of improper manufacturing and no malfunction found as it relates to the complaint, therefore manufacturing and supplier issues have been ruled out as likely causes.
Patient Sequence No: 1, Text Type: N, H10
[71012365]
Follow-up information indicates that the user saw a flat line on the screen and heard no sound from the system. The stimulator was set at 3. 0 and the stim return value was zero. The system was recognizing the electrodes, but not detecting the nerve. It was the initial use of the electrodes and probe.
Patient Sequence No: 1, Text Type: D, B5
[102605626]
Corrected information: no eval explain code. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2017-00056 |
| MDR Report Key | 6326517 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-02-13 |
| Date of Report | 2017-01-18 |
| Date of Event | 2017-01-16 |
| Date Mfgr Received | 2017-02-15 |
| Device Manufacturer Date | 2016-02-17 |
| Date Added to Maude | 2017-02-13 |
| 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 | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE 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 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? EMG ELECTRODE |
| Generic Name | ELECTRODE, NEEDLE |
| Product Code | GXZ |
| Date Received | 2017-02-13 |
| Returned To Mfg | 2017-02-13 |
| Model Number | 8227411 |
| Catalog Number | 8227411 |
| Lot Number | 0210846275 |
| 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 | 2017-02-13 |