MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2016-05-06 for NIM-ECLIPSE? ELECTRODE 945DSN2280 manufactured by Medtronic Xomed Inc..
[44667488]
Concomitant medical products: 945eclc: controller 945eclc eclipse, s/n (b)(4), lot 206744915, manufactured: 02/27/201,3 product code: gwf, 510k: k050798. Product evaluation: analysis results not available; device not returned for evaluation. 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
[44667489]
It was reported that after a procedure to address right anterior vertebral tethering from t11-l3, the "patient had three full thickness burn (3rd degree) evident around the electrode pair sites of neuromonitoring leads, com a electrode site and left first dorsal i nterosseous site (lfd) lead site. All other lead sites showed no sign of heating or burn. " it was confirmed that the patient's burns have healed and that no interventions were required to treat them.
Patient Sequence No: 1, Text Type: D, B5
[101833469]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2016-00133 |
| MDR Report Key | 5637949 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2016-05-06 |
| Date of Report | 2016-04-12 |
| Date of Event | 2016-03-24 |
| Date Mfgr Received | 2016-04-12 |
| Date Added to Maude | 2016-05-06 |
| 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-ECLIPSE? ELECTRODE |
| Generic Name | ELECTRODE, NEEDLE |
| Product Code | GXZ |
| Date Received | 2016-05-06 |
| Model Number | 945DSN2280 |
| Catalog Number | 945DSN2280 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other | 2016-05-06 |