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Auragen™

INTEGRA NEUROSCIENCES IMPLANT (FRANCE) · Model AU1X4PD · UDI-DI 10381780036166

GYC Prescription

510(k) clearances

115

Adverse events

Recalls

Facilities

Description

The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical Electrodes are available with platinum contacts and vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested.

Recalls

Date	Firm	Reason
2019-06-18	Ad-Tech Medical Instrument Corporation	Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they
2013-03-18	Integra Burlington MA, Inc.	If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit,
2012-12-18	Ad-Tech Medical Instrument Corporation	The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture an
2011-10-05	CareFusion 209 Inc.	CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annot
2011-10-05	CareFusion 209 Inc.	CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annot
2011-10-05	CareFusion 209 Inc.	CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annot

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.