On 01-Jun-2020, US-FDA has released a recall alert for class I medical Device– 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
Device Use: This device is used during a deep brain stimulation (DBS) procedure which provides images of a patient’s brain to help surgeons navigate surgical tools and implants used.
Device Incident for Recall: Medtronic (the manufacturer of this medical device)-recalled the auto-registration feature of the StealthStation DBS Software due to inaccuracies caused by minor patient movements during the auto-registration process when used with NexFrame during a DBS procedure, which may not be detected by the surgeon or the device system. This may provide inaccurate registration data which could lead surgeons to inaccurately navigate lead placement during image guided DBS procedures. This could result in serious or life-threatening harm to patient.
Device Case Reports: Medtronic has received a total of 33 medical device reports (Data as of June 2020). Out of 33 reports, 22 were related to device malfunction and 11 reports were related to injuries.
Class I MD recall: This device falls under the category of Class I medical device, as per the classification system by US-FDA. This is the most serious type of recall because use of these devices might cause serious injuries or death.
Recalled Devices:
On 09-Aug-2019, Medtronic initiated the recall by notifying 54 consignees about the affected product which were distributed during the period of 01-Feb-2016 to 01-May-2019. The below models of the device were affected with recall.
Key information to Physicians:
To weigh the benefits vs. risks of fiducial-based or fiducial-less registration methods
Following the O-arm auto-registration step, but prior to using the StealthStation DBS Software with the NexFrame Stereotactic System and O-arm Imaging System for intraoperative navigation:
- 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 to the surgical plan.
- Use the planning functionality in the software, as described in the indications for use, to compare the cannula to 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 on how to use the device and software. In addition, Medtronic has an updated training program to inform physicians of the inaccuracies due to undetected patient motion that resulted in this recall. FDA is continuing to work with Medtronic to determine whether additional mitigations may be needed.
For queries on this device recall: Health care professionals and distributors can contact Medtronic through following channels:
Via Phone: 1-888-826-5603
Via email: [email protected].
Voluntary ADR reporting:
Health care professionals and consumers are advised to report the adverse reactions or quality problems experienced with the use of this medical device to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
- Complete and voluntarily submit the report Online.
- Regular Mail or Fax: Download form FDA’s MedWatch zone, or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800- FDA-0178.