The FDA is informing the public that Medtronic has issued a corrective recall for its NIM Vital Nerve Monitoring System after receiving reports of false negative responses. While the recall does not involve a removal of the product from places of their use or sale, consumers should be aware that use of an uncorrected product could cause major injury or even death.
Indicated for use during surgery, the NIM Vital Nerve Monitoring System allows healthcare providers to “locate, monitor, and stimulate the nerves of the skull (cranial) and spine,” in addition to the connective nerves from the brain and spinal cord to muscles and/or sensory cells, or the sites of peripheral motor and mixed-motor-sensory, respectively. To protect a patient from nerve damage during a procedure, an electromyography (EMG) tone is issued from the system when the probe is put on a nerve.
Officials say false negative responses can occur when a device fails to sound an EMG tone when the NIM probe is on the nerve. Therefore, use of a defective product (a product without the proper correction) puts a patient at risk of facial nerve damage, general nerve damage, as well as the weakening (paresis) or even paralysis of nerves, among other major adverse health outcomes.
To date, Medtronic has received reports of 10 injuries and no deaths connected to the problem.
In light of the issue, all impacted individuals should be notified of the product’s potential to produce a false negative output in the event that “stimulation is applied but no EMG output is identified.” Until a given NIM Vital System is upgraded to software version version 1.5.4, a medical provider should follow their organization’s protocols to minimize the risk of nerve injury to a monitored patient due to a potential false negative output. If monitoring of patient is compromised, “alternate monitoring, surgical skills, experience and anatomical knowledge,” should be applied to mitigate nerve damage.
An Urgent Medical Device Correction communication sent in June 2024 to all Medtronic customers impacted by the recall may the following recommendations:
- Locate any affected products in inventory.
- Fill out and submit the enclosed customer confirmation form via email to neuro.quality@medronic.com.
- Distribute the letter within the customer’s organization and all organizations that should be made aware of the correction.
- Maintain a copy of the communication as an official record.
U.S. customers are asked to direct any recall-related questions to their Medtronic Representative or to the Medtronic Customer Quality team at RS.JaxProductQuality@medtronic.com.
As the FDA continues to oversee this recall, healthcare professionals and consumers are instructed to report any related adverse events to the agency’s MedWatch program.
If you or a loved one has suffered an adverse health outcome that can be attributed to the improper use of a NIM Vital Nerve Monitoring System, we urge you to get in touch with our team. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for your rightful compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.