MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-08-12 for VIKING SELECT 982A0365 manufactured by Natus Neurology, Incorporated.
[22729338]
1) registered internally as a complaint (b)(4) for further investigation by manufacturer. 2) complainant did not supply specific details regarding all of patient attributes. (patient age at time of event) and (patient weight) set equal to "0" (zero) in order to provide data entry required by esubmitter software. 3) device evaluated by manufacturer: 3. 1) complainant evaluated the viking select system on site, checked the system outputs, evaluated several items, and concluded the viking select system is not the cause of the burns. 4) a separate mdr has been created and submitted for the electrodes used, p/n 019-409000, l/n 509329 (ref mdr 3010611950-2015-00010). 5) electro-cautery equipment was in use by the complainant at the same time as the natus device in question. There are known risks associated with such device to device combinations where electrodes can intercept stray radio frequency energy and result in thermal heating. Natus safety information supplied to end users states such interactions exist and warns end users that electrode disconnection may be needed to avoid such interactions (ref natus safety reference guide, label #269-594705).
Patient Sequence No: 1, Text Type: N, H10
[22729339]
During a posterior lumbar interbody fusion procedure using natus viking select emg system p/n 982a0365, the customer has reported burns to the patient at the electrode site while performing emg stimulation and monitoring. The burns occurred when using monopolar electrocautery equipment (not a natus device) for the surgical incisions during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010611950-2015-00015 |
| MDR Report Key | 4996104 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-08-12 |
| Date of Report | 2015-07-14 |
| Date of Event | 2015-07-09 |
| Date Mfgr Received | 2015-07-14 |
| Device Manufacturer Date | 2004-09-21 |
| Date Added to Maude | 2015-08-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RANDALL MOOG |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal | 53562 |
| Manufacturer Phone | 6088298802 |
| Manufacturer G1 | NATUS NEUROLOGY INCORPORATED |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53562 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIKING SELECT |
| Generic Name | ELECTROMYGRAPH |
| Product Code | IKN |
| Date Received | 2015-08-12 |
| Model Number | 982A0365 |
| Catalog Number | 982A0365 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS NEUROLOGY, INCORPORATED |
| Manufacturer Address | 3150 PLEASANT VIEW ROAD MIDDLETON WI 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-12 |