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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00522-1
Product Name/Description	NIM Vital Nerve Monitoring System CONSOLE NIM4CM01 NIM 4.0 Model number: NIM4CM01 Serial number: All NIM Vital Nerve Monitoring systems manufacture installed with the NIM Vital System software version v1.4.3 or earlier PATIENT INTERFACE NIM4CPB1 NIM 4.0 Model number: NIM4CPB1 Serial number: All NIM Vital Nerve Monitoring systems manufacture installed with the NIM Vital System software version v1.4.3 or earlier ARTG 169810 (Medtronic Australasia Pty Ltd - Stimulator, nerve locator)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	26/06/2024
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Customers reported experiencing false negative responses (the condition where the probe is on a nerve, but no EMG tone is triggered) while using the NIM Vital Nerve Monitoring System. If this problem presents during procedure, potential risks may include delay or cancellation of procedure, nerve damage, facial nerve damage, nerve paresis, and nerve paralysis. Between April 1, 2020, and May 31, 2024, Medtronic has received 70 reports related to this problem, including 10 serious harm reports, one resulting in a cancelled case, the others reporting nerve damage, facial nerve damage, nerve paresis, or nerve paralysis.
Recall Action	Product Defect Correction
Recall Action Instructions	- Customers are to identify affected products within their inventory. The product is not required to be returned to Medtronic, because a NIM Vital System software version 1.5.4. has been deployed and is readily available to rectify the problem. - A Medtronic Representative will contact customers to install the new software version 1.5.4 for correction of the impacted product. - Patients who are currently being monitored with the NIM Vital Nerve Monitoring System must continue to follow their medical protocols in place.
Contact Information	0413 444 894 - Anna Ferraro