MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7; INSTRUMENT, STEREOTAXIC

Model Number 9733858

Device Problem Imprecision (1307)

Patient Problems No Known Impact Or Consequence To Patient (2692); Radiation Exposure, Unintended (3164)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.Once a new scan was preformed to compare the previously tapped hole, an inaccuracy was observed on the inferior-superior plane on trajectory 2 view.The surgeon was certain the frame was not moved.The surgeon had a practice of checking the "perc" frame was in position every time before scanning.The procedure, imaging, and navigation were not aborted.There was no impact on patient outcome.No further actions were taken as the issue was considered to be resolved during the call.No complications were reported/anticipated.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the navigation system functioned as designed and the reported issue could not be replicated.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: a software investigation analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that the analysis was inconclusive and probable cause was unable to be determined.If information is provided in the future, a supplemental report will be issued.

Event Description

It was later noted that there was a 10-mm inaccuracy along with total delay of 10-minutes to the procedure.

Manufacturer Narrative

The patient weight was received and added.Patient age was not available from the site.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION® S7
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8500843
• MDR Text Key: 141626253
• Report Number: 1723170-2019-01656
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/19/2019

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: Health Professional
• Device Model Number: 9733858
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 04/11/2019; 05/27/2019; 07/18/2019
• Supplement Dates FDA Received: 05/08/2019; 06/06/2019; 07/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 70