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

Model Number S7

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 01/08/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016 a medtronic representative, following-up at the site, reported the alleged inaccuracy was reported to have been 2-3 millimeters off.On (b)(6) 2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.On (b)(6) 2016 software analysis was unable to determine probable cause with the information provided.The medtronic representative noted that they were shifting the anatomy in an attempt to redirect a tap that was already engaged, therefore, making their approach look correct when it may actually not have been what they desired.It is suspected that the frame to patient relationship changed which may have invalidated the registration.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A medtronic representative reported that, while in a spine procedure, using a navigation system and an imaging system, the surgeon deemed the three screws were misplaced and alleged an inaccuracy.No specific measurement was given for the alleged inaccuracy.The surgeon has a unique approach that he has developed to place bilateral 'claw screws'.One of the screws went through t3 into t2 and another of the surgeon's pedicle screws felt inaccurate at t6.Screws were placed from t2 to the pelvis.Accuracy was checked periodically throughout the procedure by putting a navigated instrument on known anatomy, this was done without difficulty.Screws were re-directed using fluoroscopy without issue, or any known patient complication, and the procedure proceeded as planned.The medtronic representative noted that they were shifting the anatomy in an attempt to re-direct a tap that was already engaged, therefore, making their approach look correct when it may actually not have been what they desired.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.

Manufacturer Narrative

The instructions for use, which accompany this device, states: "warning: make sure that the reference frame assembly is rigidly attached and locked (tightened) with respect to the relevant anatomy.If the post or clamp moves in relation to the anatomy, navigational inaccuracy may result." and "warning: do not bump or reposition the reference frame after registration.Such movement may result in inaccurate navigation.If the reference frame moves in relation to the patient anatomy at any time after registration, you must reregister.".

• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 5397451
• MDR Text Key: 37085570
• Report Number: 1723170-2016-00127
• 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: 03/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/08/2016
• Initial Date FDA Received: 01/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2014
• 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: 55 YR
• Patient Weight: 73