MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-10-17 for NIM? EMG ELECTRODE 8227410 manufactured by Medtronic Xomed Inc..
[57687098]
Concomitant medical products: 8253001: mainframe 8253001 nim response 3. 0, s/n (b)(4), lot 207333371 manufactured: 08-22-2013; 8253200: patient interface 8253200 response 3. 0, s/n (b)(4), lot 207304806 manufactured: 08-19-2013; 8225101: probe 8225101 5pk std prass flush, lot unknown. Product evaluation: analysis results not available; device not returned, it was discarded after use. The instructions for use provide the following: to avoid alternate site patient burns or lesions: do not activate the electrosurgical instruments (esu) while stimulator is in contact with tissue; do not leave stimulating electrodes or probes in surgical field; do not store stimulating electrodes or probes in electrosurgical instrument holder; do not allow a second surgeon (for example, fat harvesting) to use electrosurgical instruments while stimulator is in use; do not activate electrosurgical instrument for prolonged periods while esu is not in contact with tissue; do not activate electrosurgical instrument near the recording or stimulating electrodes; do not allow patient interface boxes or recording / stimulating electrodes sites to be flooded with saline; do not allow excessive stray ac or dc leakage currents from patient connected equipment; avoid creating an unintended grounding path through applied electrodes. Practitioner is responsible for proper use, periodic safety certification of patient connected equipment, and ac power grounding in accordance to the appropriate iec 60601-1 and/or iec 60601-1-1 medical safety standard. 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
[57687099]
It was reported that "after the drapes were taken off the patient and the leads for the nim were removed a burn was noted on the patients upper mid chest near her throat were a lead for the nim was placed that was roughly a little larger than the size of a pencil eraser. " additional information states that when undraping the patient upon completion of the procedure, they noticed that there was a tiny pinprick where the ground electrode had been with a white circle surround the tiny hole; perfectly in the center. The white color is what made it stand out as a burn and not a skin reaction to the electrode. Bacitracin ointment was applied to the area for protection, no additional interventions were performed. There was no serious injury reported.
Patient Sequence No: 1, Text Type: D, B5
[102578512]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2016-00343 |
| MDR Report Key | 6034626 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-17 |
| Date of Report | 2016-09-21 |
| Date of Event | 2016-09-20 |
| Date Mfgr Received | 2016-09-21 |
| Date Added to Maude | 2016-10-17 |
| 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 |
| Product Code | GXZ |
| Date Received | 2016-10-17 |
| Model Number | 8227410 |
| Catalog Number | 8227410 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-10-17 |