Class I recall initiated due to inaccuracies displayed during surgical procedures
Medtronic is recalling the Synergy Cranial Software and StealthStation S7 Cranial Software used with the StealthStation Surgical Navigation System due to reports of incorrect information displaying during biopsy procedures. The company said this could result in serious or life-threatening patient harm.
The Synergy Cranial Software and StealthStation S7 Cranial Software, used with the StealthStation Surgical Navigation System, provides detailed three-dimensional (3-D) images of a patient's brain to help neurosurgeons safely navigate surgical tools and implants used during brain surgery.
During a biopsy procedure, Medtronic said the software monitor may show that the tip of the surgical tool has not yet reached the planned target and may prevent the neurosurgeon from being able to accurately see the location of surgical tools in the patient's brain. In the event this software defect occurs, the neurosurgeon could potentially insert the surgical tool too deeply and damage the patient's healthy tissue, brain or blood vessels.
On Sept. 21, 2018, Medtronic sent an Urgent Medical Device Correction notice to customers. The notice provided the following mitigation to eliminate the risk of damaging healthy tissue:
Do not set a projection longer than the length of the surgical plan;
Follow the Cranial Software Pocket Guide, and always use the Biopsy Needle Mechanical Depth Stop; and
Ensure the Navigate Instrument Tip setting is selected prior to locking the trajectory and navigating the instrument.
The notice also instructed customers to take the following actions:
Review the notice and ensure appropriate staff are aware of the issue;
Sign and date the Consignee Response Form attached to the notice, and return the form to Medtronic by email at RS.NavFCA@Medtronic.com (link sends e-mail) or fax to Medtronic Technical Services at 651-367-7075 within 30 days of receipt.
On Dec. 28, Medtronic reported they were continuing to follow up with customers about their Urgent Medical Device Correction over the next months.
Affected model numbers include:
9733763 with software versions 2.2.0, 2.2.5, 2.2.6, 2.2.7
9735585 with software versions 3.0.0, 3.0.1, 3.0.2, 3.1.0
All affected devices were manufactured from Aug. 31, 2011, to Oct. 16, 2018, and were distributed between the same dates.
Customers who have questions or need additional information or support related to this recall should contact Medtronic Technical Services at 1-888-826-5603. Healthcare professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by fax to 1-800-FDA-0178.