The recall was issued due to inaccuracies caused by minor patient movements during the software's autoregistration process when used with the company's NexFrame stereotactic imaging system and O-arm imaging system during a DBS procedure. These errors may not be detected by the surgeon or the device system, according to the FDA.
"This may provide inaccurate registration data which could lead surgeons to inaccurately navigate lead placement during image guided DBS procedures," the FDA wrote in its recall information summary. "This could result in serious or life-threatening patient harm."
The FDA classified the action as a class I recall -- its most serious type. A total of 33 medical device reports have been received by the FDA as of June. Of these, 22 were related to device malfunction and 11 were related to injuries, the FDA said.
Medtronic sent urgent medical device correction letters on August 9, 2019, to the 54 affected customers, advising physicians to weigh the benefits against the risks of fiducial-based or fiducial-less registration methods, according to the FDA. It also provided new instructions.
After the O-arm autoregistration step has been completed, but before using the StealthStation DBS software with the NexFrame stereotactic system and O-arm imaging system for intraoperative navigation, customers should do the following:
- Assess navigational accuracy by verifying the accuracy of the registration on several known anatomical landmarks, as described in the indications for use, before using the registration for navigation.
- Use the StealthMerge functionality in the software, as described in the indications for use, to compare the actual location of the cannula or lead with the surgical plan.
- Use the planning functionality in the software, as described in the indications for use, to compare the cannula with the planned trajectory. This can be accomplished by making an additional plan along the axis of the cannula to evaluate cannula position.
Medtronic has also added instructions to the label and has produced an updated training program to inform physicians of the inaccuracies that resulted in the recall. The FDA said it's continuing to work with the company to determine if additional mitigation measures are needed.
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