Medtronic has recalled the auto-registration aim in the StealthStation deep brain stimulation (DBS) tool because of the inaccuracies true by DBS procedures, essentially based on a peek on the US Food and Drug Administration (FDA) web build of abode.
The StealthStation DBS tool with the NexFrame stereotactic machine and O-arm imaging machine affords pictures of the brain to encourage surgeons navigate surgical instruments and implants mature true by DBS.
The inaccuracies in the auto-registration aim of the tool are brought about by minor patient actions true by the auto-registration route of when mature with NexFrame true by a DBS route of, that may work undetected by the surgeon or the tool machine, the FDA says.
“This may present mistaken registration recordsdata, which may lead surgeons to inaccurately navigate lead placement true by image-guided DBS procedures. This may perhaps consequence in excessive or lifestyles-threatening patient trouble,” the company warns.
The FDA has identified this as a Class I recall, essentially the most excessive form, because of the the risk of excessive trouble or demise. Thus some distance, this bellow is the realm of 33 clinical tool experiences: 22 connected to tool malfunction and 11 connected to accidents.
The recall covers tool model 3.0 or more moderen (3.0, 3.1, 3.1.1) with StealthStation DBS license or StealthStation S8 tool with Stealth DBS license. The tool change into disbursed between February 1, 2016 and Could perchance 1, 2019.
Medtronic has notified all clients with the affected product concerning the recall by an pressing clinical tool correction letter. The letter advises customers to weigh the advantages vs dangers of fiducial-essentially based or fiducial-much less registration suggestions and affords the next directions:
Following the O-arm auto-registration step, however earlier than the usage of the StealthStation DBS tool with the NexFrame stereotactic machine and O-arm imaging machine for intraoperative navigation:
1. Assess navigational accuracy by verifying the accuracy of the registration on several acknowledged anatomical landmarks, as described in the symptoms for utilize, earlier than the usage of the registration for navigation.
2. Utilize the StealthMerge functionality in the tool, as described in the symptoms for utilize, to review the actual region of the cannula or consequence in the surgical scheme.
3. Utilize the planning functionality in the tool, as described in the symptoms for utilize, to review the cannula to planned trajectory. This may be completed by making an further scheme along the axis of the cannula to eliminate into consideration cannula build of abode.
The FDA is persevering with to work with Medtronic to search out out whether further mitigations may be wanted.
Healthcare experts and distributors with questions about this recall may quiet contact Medtronic by phone at 1-888-826-5603 or e mail at [email protected].
Negative reactions or quality considerations connected to this recall must be reported to the FDA’s MedWatch program.
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