Medtronic has updated the indications for use and the warning statements for its Navlock trackers, following two patient deaths. The trackers—which are part of its StealthStation navigation system—had been used alongside third-party instrumentation in a number of cases resulting in patient injury.
The previous indication for use read, “The NavLock tracker is intended to enable navigation of instrumentation used for pedicle preparation during spinal fusion and interbody procedures with a Medtronic computer-assisted surgery system.”
The revised indication now reads, “The NavLock trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with the Medtronic StealthStation surgical navigation system. The NavLock trackers should only be used with Medtronic instruments.”
The previous warning statement read, “The NavLock tracker is designed and tested for use only with Medtronic instruments. Use with any unapproved instrument could compromise accuracy and safety.”
The strengthened version now 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.”
In safety notice issued by the company, Medtronic states, “Medtronic has not assisted in the design, instrument development, software development, process qualification, or validation of any non-Medtronic instrument for use with the NavLock tracker. Instruments manufactured by a non-Medtronic manufacturer have not been evaluated by Medtronic for compatibility with NavLock. Additionally, non-Medtronic instruments do not have corresponding “tool cards” in the StealthStation software.”
