VIKING SELECT 982A0365

MAUDE Adverse Event Report

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.

Event Text Entries

[22727439] Registered internally as a complaint (b)(4) for further investigation by manufacturer. 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. Device evaluated by manufacturer: 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. A separate mdr has been created and submitted for the electrodes used, p/n 019-409000, l/n 505800 (ref mdr 3010611950-2015-00009). 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


[22727440] 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


MAUDE Entry Details

Report Number3010611950-2015-00014
MDR Report Key4996068
Report SourceHEALTH PROFESSIONAL
Date Received2015-08-12
Date of Report2015-07-14
Date of Event2015-06-30
Date Mfgr Received2015-07-14
Device Manufacturer Date2004-09-21
Date Added to Maude2015-08-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactRANDALL MOOG
Manufacturer Street3150 PLEASANT VIEW ROAD
Manufacturer CityMIDDLETON WI 53562
Manufacturer CountryUS
Manufacturer Postal53562
Manufacturer Phone6088298802
Manufacturer G1NATUS NEUROLOGY INCORPORATED
Manufacturer Street3150 PLEASANT VIEW ROAD
Manufacturer CityMIDDLETON WI 53562
Manufacturer CountryUS
Manufacturer Postal Code53562
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVIKING SELECT
Generic NameELECTROMYGRAPH
Product CodeIKN
Date Received2015-08-12
Model Number982A0365
Catalog Number982A0365
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNATUS NEUROLOGY, INCORPORATED
Manufacturer Address3150 PLEASANT VIEW ROAD MIDDLETON WI 53562 US 53562


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-08-12

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