The company in August 2019 recalled the auto-registration feature of its StealthStation DBS software due to inaccuracies caused by minor patient movements during the auto-registration process when used with NexFrame stereotactic system during a DBS procedure. The problem — which may not be detected by the surgeon or the device system — resulted in 11 reports related to injuries and another 22 related to malfunctions, according to FDA.
Medtronic’s Urgent Medical Device Correction letters advised health providers to weigh the benefits versus risks of fiducial-based or fiducial-less registration methods, providing additional instructions to ensure navigational accuracy during a procedure.
The recall specifically involves the Medtronic StealthStation auto-registration feature from the cranial software version 3.0 or newer (3.0, 3.1, 3.1.1) with StealthStation DBS license or StealthStation S8 software with Stealth DBS License. The software was distributed from February 1, 2016 to May 1, 2019.
The news of the Class I designation comes about a year and a half after FDA issued a Class I designation of a recall involving Medtronic Synergy and StealthStation S7 cranial software used with its StealthStation surgical navigation system. The recall involved incorrect information being displayed during biopsy procedures.
“In August 2019, Medtronic received reports regarding the StealthStation DBS software auto-registration potential inaccuracy after receiving reports of entry point and lead placement inaccuracies during deep brain stimulation (DBS) lead implantation procedures,” Medtronic spokesperson David T. Young told MassDevice in a statement. “The inaccuracy is related to motion caused by patient respirations or tremor after the registration is taken but prior to image acquisition completion. This occurred when using the Nexframe stereotactic system (Nexframe) and the StealthStation autoregistration feature with the O-arm imaging system.
“The StealthStation System is intended to aid surgeons in precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. Medtronic initiated a medical device correction to notify users of the alleged issue and provide mitigations to prevent the potential issue from occurring. At the time of this classification, all actions from this field correction have been completed. At Medtronic, patient safety is our priority. We take this potential risk seriously, and we are working to ensure all Medtronic customers are fully aware of the risk and associated mitigations.”