The Food and Drug Administration (FDA) sent out a Class I recall in September 2018 covering Synergy Cranial Software due to concerns that defects in this software could endanger the health of patients undergoing brain surgery. A Class I recall from the FDA is the most serious type of recall that the agency can issue, and is issued when the FDA believes that use of the affected product is likely to cause serious injury or death to an individual.
Uses of Synergy Cranial Software
Patients who must undergo brain surgery place their lives in the hands of skilled surgeons with years of training and experience. However, even years of experience in practicing operations and procedures on this delicate organ of the human body is no guarantee that complications and mistakes will not occur. To help reduce the likelihood of these unfortunate mistakes from occurring, modern medical imaging technology permits surgeons to observe a real-time, three-dimensional image of the patient’s brain using specialized imaging software. Such software permits the surgeon to also observe (again, in real-time) the location of medical tools and devices that the surgeon is using to operate on portions of the patient’s brain.
Dangers of Defective Synergy Cranial Software
When such imaging software works as intended, it can be a great tool to assist surgeons in operating with precision and avoid causing further injury to other parts of the brain. When there is a defect in this software, however, disaster can ensue. Specifically, it is alleged that defects in the Synergy Cranial Software can result in an image of the brain in which the locations of surgical tools are not accurately represented. In procedures in which even millimeters matter, a surgeon believing that a tool he is using is in a location in the patient’s brain that it is actually not can result in the surgeon moving a tool into an area of the brain that he or she should not.
Protecting Yourself from Synergy Cranial Software Injuries
The FDA’s recall notice calls upon neurosurgeons to take certain steps in order to mitigate the risk of injury or death occurring from the use of Synergy Cranial Software. The manufacturer of this software, Medtronic, continues to follow up with practitioners and users of the Synergy Cranial Software in order to help ensure that these important mitigating steps are being implemented. Neurosurgeons and others who continue to use Synergy Cranial Software for procedures without taking the mitigating actions recommended by the manufacturer may be civilly liable for any harm, injuries, or deaths that occur as a result.
It also remains to be seen if Medtronic is responsible for any injuries or harm that befalls patients hurt as a result of the Synergy Cranial Software. If Medtronic knew or should have known that this software was defective and did not take reasonable measures to fix the defect or otherwise warn the public, then Medtronic may well indeed be responsible in part for any harm to patients.
Have I Been Injured by a Synergy Cranial Software Defect?
If you or a loved one have recently undergone a brain procedure that may have involved the use of Synergy Cranial Software and you are experiencing consequences such as a coma, stroke, blood clots, infections, or impairment of your coordination or other similar complications, you may be entitled to compensation from the surgeon and/or Medtronic. These lawsuits require quick action and are extremely complex to investigate and present, so it is vital that you seek legal help with your case as soon as possible.
Parker Waichman LLP offers individuals who believe they may have been harmed by Synergy Cranial Software a free initial consultation in which they can discuss their case with a member of Parker Waichman LLP’s legal team. Call 1-800-YOURLAWYER (1-800-968-7529) to set up your Synergy Cranial Software consultation today.
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