MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative inspected the navigation system onsite and was able to duplicate the reported issue.When the locking ring was not locked tight and the guide stem was moved after locking the trajectory, the biopsy needle would not navigate.The issue was not the camera or navigation system's ability to 'see' the needle.When the representative tightly locked the ring, the biopsy needle was passed into field of view several times with successful navigation visualization.The passive biopsy needle reflected green on the monitor.It was noted that the biopsy needle is only tracked when it is moving along the trajectory of the plan.If the guide stem is moved to where the biopsy needle is not travelling along the trajectory of the plan, the biopsy needle will not be tracked.No parts were returned to the manufacturer for evaluation.

Event Description

A medtronic representative reported that while in a cranial biopsy procedure with the navigation system, it was not possible to track the biopsy needle.The biopsy needle was not tracking during a navigus biopsy.The site reset the target and entry of the plan, updated the entry of the plan using the navigus probe, and re-locked the trajectory at least 3 times.The site also tried using another biopsy needle, rebooted the application, re-positioned the camera and was still unable to track the new needle.The site decided to use the suretrak (orange) tracker to track the biopsy needle.There was a reported delay of 45 minutes to the procedure as a result of this issue and no impact on the patient outcome.Pathology confirmed a positive sample was obtained.

Manufacturer Narrative

The software investigation found that the reported event was unrelated to a software issue.The software functioned as designed.

• Brand Name: STEALTHSTATION S7 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7110203
• MDR Text Key: 94934237
• Report Number: 1723170-2017-05103
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• 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,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2013
• 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 Age: 62 YR
• Patient Weight: 55