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

Model Number S7

Device Problems Image Reversal (1358); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2016

Event Type  malfunction  

Manufacturer Narrative

The medtronic representative reviewed localizing images and thumbnails from this patient and they appear to be in the same orientation that they transferred to the navigation system in.It is determined likely that the site radiographic technologist (rt) labeled the incorrect orientation on the imaging system pendant.Recommendations made to the rt for proper protocol regarding correct orientation.Subsequent procedures performed with this system have had no issues, system functioned properly on 10/03/2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.No further issues have been reported.

Event Description

A medtronic representative reported that, while in a spine sacroiliac joint (sij) procedure, the surgeon alleged the images flipped (r/l and s/i) while using an imaging system navigated spin within synergy spine 2.1 software.The surgeon was confident that the orientation of the imaging system exam did not match the orientation of the exam loaded into the navigation system.The medtronic representative switched the exam orientation on the navigation system.The surgeon opted to continue and completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.

Manufacturer Narrative

Correction: device manufacture date provided.

• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6062706
• MDR Text Key: 58613139
• Report Number: 1723170-2016-02761
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/03/2016,12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Date Report to Manufacturer: 10/03/2016
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2012
• 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
• Treatment: (B)(4)
• Patient Age: 67 YR
• Patient Weight: 63