MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number I7

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Brain Injury (2219); Injury (2348); Iatrogenic Source (2498)

Event Date 04/19/2016

Event Type  Injury  

Manufacturer Narrative

A medtronic representative, at the site, reported that the surgeon was using device in an off-label manner.Use error required a new burr hole.System was fully functional.Resolution confirmed at time of event.No parts were replaced.No parts have been received by manufacturer for analysis.No further issues have been reported.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's stealthstation s7 system and biopsy guide.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.User problem known - no evaluation necessary.

Event Description

A medtronic representative reported that, while in a cranial procedure, the surgeon alleged that the precision aiming device moved when the surgeon was drilling through the device.This movement was directly identified at the time.They had not breached the dura.The surgeon opted to abandon the use of the navigation system and created a new burr hole using a non-medtronic navigation system.The medtronic representative notified the surgeon, prior to the start of surgery, that was off-label use of the product.Delay in therapy was 20 minutes.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's stealthstation s7 system and biopsy guide.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

Manufacturer Narrative

A medtronic representative, following up with the site, reported that the surgeon didn't abort navigation.The navigation system was used to complete the surgery, which was a tumor ablation using a non-medtronic laser system.The medtronic representative confirmed the surgeon opted to use the technique of drilling through the precision aiming device when doing a non-medtronic laser procedures.The medtronic representative reported the site is aware the technique is off label.The medtronic representative found the inaccuracy was off "by a few centimeters" in the lateral direction.A second burr hole was created because the surgeon aborted the trajectory set-up for placement of a non-medtronic bolt.The medtronic representative reported the surgeon: "used the mother as 'ufo' and our navigus probe to line up a new trajectory and proceeded with the procedure that way.Again, he knows this is off-label." the instructions for use which accompanies this device contains instructions for proper usage of the precision aiming device and the following warning: "warning: the position of the anatomy is defined by the position of the patient reference.If the patient reference moves with respect to the anatomy after you register the patient, navigation will be inaccurate.Make sure the vertek® arm is locked securely in position.If the arm slips after registration, re-secure it and register the patient again before navigating.".

• Brand Name: STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 5652055
• MDR Text Key: 45092730
• Report Number: 1723170-2016-00838
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: I7
• Device Catalogue Number: 9734060
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 81