This article is more than 5 years old. Information may no longer be current.

FDA discloses information related to adverse events after use of non-Medtronic devices

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

In a letter to health care providers, the FDA provided information regarding adverse events reported during or following procedures that involved non-Medtronic surgical stereotaxic navigation instruments with Medtronic’s NavLock Tracker.

According to the letter, on May 1, Medtronic reported in a notice that they are aware of occurrences of minor and serious injuries, including two patient deaths, following procedures that involved the use of non-Medtronic instruments with Medtronic’s NavLock Tracker. Medtronic notified the FDA of plans to update their product labeling to clarify indications of use and warning statements.

The revised statements stress the necessity to use the NavLock Tracker only with other Medtronic instruments, as it is only designed and tested to work with those instruments.

Reference:

www.fda.gov