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

Model Number S7

Device Problem Imprecision (1307)

Patient Problems Spinal Column Injury (2081); Injury (2348); Iatrogenic Source (2498)

Event Date 05/04/2017

Event Type  Injury  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

Event Description

A medtronic representative reported that, while in a spinal fusion, the surgeon felt an imprecision occurred when using the navigation system.The surgeon reported that a post-operative spin had a non-preferred location and decided to revise the screws.A confirmation image of the second placement had an appropriate location.It was reported that the screws used were not navigated and that they were hand screws.No additional information was provided.There was a reported delay to the procedure of less than 1 hour due to this issue.

Manufacturer Narrative

(b)(4).The software investigation was unable to determine probable cause without further information since the behavior cannot be replicated during system checkout.

Manufacturer Narrative

Additional information: upon further follow-up in regards to level/amount of inaccuracy noted, it was reported that there was no measurement taken or direction noted.

Manufacturer Narrative

The site reported that the surgeon was unhappy with the placement of one screw, so he revised it.The site rep also reported that the surgeon does not usually navigate his driver for screw placement.He uses navigated awl or tap to establish the area in which he wants to place his screws.Site rep also reported that they have been covering cases with the site and the reported even has not recurred.Medtronic software team has also reviewed this event along with similar event reported within the past year.The two most recent complaints could not be replicated and received a passing system check out.A search of the qms systems yielded no related occurrences.These findings do not indicate a sw issue at this time.Recommended a site training on navigation accuracy techniques and instrumentation management.

• 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: sam saleh ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 6606399
• MDR Text Key: 76479331
• Report Number: 1723170-2017-02311
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: Yes
• 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: 08/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2016
• 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: 53 YR
• Patient Weight: 112