FDA Issues Warning on Medtronic Surgical Navigation Tools After Patient Deaths

At least two patients have died and nearly a dozen have been injured when doctors tried to use non-Medtronic medical instruments with the company’s NavLock Tracker surgical navigation system, according to recent warnings issued by federal safety officials. 

In a letter issued by the FDA on May 2, healthcare providers were warned not to use surgical sterotaxic navigation instruments that were not made by Medtronic, or were not approved for use with the Medtronic surgical navigation devices.

The warning came just days after Medtronic sent out a safety notice to healthcare providers (PDF) about the same problems.

The Medtronic NavLock Tracker is a medical device designed to be used with the Medtronic StealthStation Surgical Navigation System. The system helps guide medical instruments to the correct surgical location during spinal fusion and interbody procedures. The FDA has also approved a number of other devices for use with the NavLock Tracker.

At least 196 reports involving problems associated with the tracker have been received by the FDA since January 1, 2013, including at least two deaths and 11 cases of serious injury that occurred when doctors tried to use unapproved or non-Medtronic devices with the NavLock Tracker. Both deaths, and the majority of the injuries, were associated with spinal surgery procedures.

As a result of the incidents, Medtronic is revising the label warnings and Indications for Use statements. The current label warning states:

The NavLock Tracker is designed and tested for use only with Medtronic instruments. Use with any unapproved instrument could compromise accuracy and safety.

The new label warning reads:

The NavLock Tracker is designed and tested for use only with Medtronic instruments. The use of non-Medtronic instruments with the NavLock Tracker may result in inaccuracy, leading to serious injury or death.

The FDA is recommending that health care providers do not use surgical sterotaxic instruments not approved by the FDA for use with the Medtronic NavLock Tracker or StealthStation. The agency also calls on healthcare professionals to repeatedly assess surgical accuracy during a procedure when using any surgical navigation system, and to make sure to only use surgical sterotaxic instruments that have been identified as being compatible with the surgical navigation system being used.

The agency has called for any adverse events related to the use of the Medtronic NavLock Tracker to be reported to the FDA’s MedWatch adverse event reporting system.

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