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 2017-10-11 for NIM? EMG ELECTRODE 8227410 manufactured by Medtronic Xomed Inc..
[90312348]
Product evaluation: the electrodes were received for analysis. There was no damage or anomalies in the construction of the electrodes that would result in the reported event. The end to end resistance for each side of the paired electrodes shall be <(><<)>2. 0 ohms and infinite ohms between needle tips [no short circuit]. The actual measurements of the red paired were as follows - one pole measured 1. 7 ohms and the other 1. 8 ohms with no short circuit between poles (in specification). The actual measurement of the blue paired were as follows - both poles measured 1. 7 ohms with no short circuit between poles (in specification). The red/white and green end to end ohms resistance shall be less than 2. 5 ohms; the actual measurements for the red/white was 0. 9 ohms; the actual measurements for the green was 0. 9 ohms (both were in specification). The information most likely indicates a failure to adhere to the ifu warnings. ** the instructions for use warns: to avoid alternate site patient burns or lesions:? A. Do not activate the electrosurgical instruments (esu) while stimulator is in contact with tissue. ? B. Do not leave stimulating electrodes or probes in surgical field. ? C. Do not store stimulating electrodes or probes in electrosurgical instrument holder. ? D. Do not allow a second surgeon (for example, fat harvesting) to use electrosurgical instruments while stimulator is in use. ? E. Do not activate electrosurgical instrument for prolonged periods while esu is not in contact with tissue. ? F. Do not activate electrosurgical instrument near the recording or stimulating electrodes. ? G. Do not allow patient interface boxes or recording / stimulating electrodes sites to be flooded with saline. ? H. Do not allow excessive stray ac or dc leakage currents from patient connected equipment; avoid creating an unintended grounding path through applied electrodes. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[90312349]
The physician reported that when setting up for a cochlear implant the skin where the nim electrodes would be applied was disinfected using their? Normal procedure?. Following the procedure it was noted that a? Burn wound occurred between the ground cord and stim return cord located: width - 1 cm and depth - 0. 1 cm - 0. 3 cm (one side to the other side).? The physician removed the? Burn parts and stitched the wound.? Following the procedure, the ground cord and stim return cord were tested; both? Acted normally?. It was confirmed that during the procedure a? Bi-polar conmed? Was used and the cables of the? Bi-polar conmed? And the electrodes were side by side. At this time, the patient? S skin is healing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2017-00360 |
| MDR Report Key | 6942079 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-11 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-09-14 |
| Date Mfgr Received | 2017-09-14 |
| Device Manufacturer Date | 2016-11-03 |
| Date Added to Maude | 2017-10-11 |
| 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 | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| 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? EMG ELECTRODE |
| Generic Name | ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH |
| Product Code | IKT |
| Date Received | 2017-10-11 |
| Returned To Mfg | 2017-09-26 |
| Model Number | 8227410 |
| Catalog Number | 8227410 |
| Lot Number | 0212244318 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-11 |