MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-01-27 for NIM? EMG ELECTRODE 8227411 manufactured by Medtronic Xomed Inc..
[65960378]
Concomitant medical products. 8225101? Probe, 5pk std prass flush tip; lot number - 0210923677; manufacture date? March 3, 2016; (b)(4); the 510k - k934426. The device has not been received. A product analysis has not been completed. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[65960379]
It was reported that intraoperative, the electrodes and probe could not detect nerves properly. The doctor had reinserted the electrodes and tried another device. The user was unable to resolve the issue. Therefore, the doctor completed the surgery without the nim system. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[68630701]
(b)(4) (lot number 0211402935): the product analysis indicates that one un-sealed 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 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. 7ohms / 1. 7ohms. 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. 9 ohms indicating an in-specification condition. This is a supplied material assembly with no out of specification condition. (b)(4) (lot number 0210923677): 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.
Patient Sequence No: 1, Text Type: N, H10
[68630702]
Additional information received indicates that the procedure performed was a middle ear surgery. The device(s) delivered non-nerve sounds that let the user know the device was not working properly. The stim was set at 2 and 3. When the stim was set at 2, the return value was 1. 99. When the stim was set at 3, the return value was 2. 99. The system recognized the electrodes when going from the set-up screen to the monitoring screen. To troubleshoot, the user reconnected the devices, reconnected the probe and electrodes and switched the mainframe off and on. It was the initial use of the electrodes and probe.
Patient Sequence No: 1, Text Type: D, B5
[102605720]
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 | 1045254-2017-00042 |
| MDR Report Key | 6283013 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-01-27 |
| Date of Report | 2017-01-04 |
| Date of Event | 2016-12-28 |
| Date Mfgr Received | 2017-02-03 |
| Device Manufacturer Date | 2016-06-07 |
| Date Added to Maude | 2017-01-27 |
| 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 | 2017-01-27 |
| Returned To Mfg | 2017-02-13 |
| Model Number | 8227411 |
| Catalog Number | 8227411 |
| Lot Number | 0211402935 |
| 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 | 2017-01-27 |