This recall involves correcting devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Affected Product
- Product Name: NIM Vital Nerve Monitoring System
- Unique Device Identifier (UDI)/Models
| GTIN/UDI Number | Product Name | Model |
|---|---|---|
| 00763000002978, 00763000395896, 00763000401597, 00763000528577 | CONSOLE NIM4CM01 NIM 4.0 | NIM4CM01 |
| 00763000002992 | CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED | NIM4CM01RF |
| 00763000002985, 00763000401603, 00763000395902, 00763000528584 | PATIENT INTERFACE NIM4CPB1 NIM 4.0 | NIM4CPB1 |
| 00763000003005 | PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB | NIM4CPB1RF |
| 00763000709341, 00763000869823 | SOFTWARE NIM4SWU143 UPGRADE V1.4.3 | NIM4SWU143 |
What to Do
- Be aware of the possibility of a false negative output from the device, where stimulation is applied but no EMG output is identified to the user.
- Follow organizational medical protocols in place for patients who are currently being monitored with the NIM Vital Nerve Monitoring System to minimize the risk of nerve injury due to a false negative output until your NIM Vital System is upgraded to software version 1.5.4.
- Rely on alternate monitoring, surgical skills, experience and anatomical knowledge to prevent damage to nerves if monitoring is compromised.
The product is not required to be returned for this issue as Medtronic is deploying NIM Vital System software version 1.5.4. to fix this issue.
In June 2024, Medtronic sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:
- Identify affected products.
- Complete and return the customer confirmation form enclosed with the letter and send it via email to neuro.quality@medtronic.com.
- Share this information in your organization and with other organizations that may be impacted by this correction.
- Keep a copy of this letter for records.
The letter also informed customers that A Medtronic Representative will contact each organization to install software version 1.5.4, which corrects the issue.
Reason for Correction
Medtronic is correcting the NIM Vital Nerve Monitoring System product due to reports of false negative responses. This can occur during procedures, where the device may fail to issue an electromyography (EMG) tone when the NIM probe is placed on a nerve.
The use of affected product may cause serious adverse health consequences, including nerve damage, facial nerve damage, nerve weakening (paresis), and nerve paralysis.
There have been 10 reported injuries and no reports of death.
Device Use
The NIM Vital Nerve Monitoring System is used during surgery to locate, monitor, and stimulate the nerves of the skull (cranial) and spine, as well as the nerves that connect the brain and spinal cord to muscles (peripheral motor) and/or sensory cells (mixed motor-sensory). The system issues an EMG tone when the probe is placed on a nerve to help prevent nerve damage during surgery.
Contact Information
Customers in the U.S. with questions about this recall should contact their Medtronic Representative or Medtronic Customer Quality at RS.JaxProductQuality@medtronic.com.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
