MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGATION STEALTH STATION S7 SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9733856

Device Problem Imprecision (1307)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

No devices were returned to the manufacturer for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used intra/peri-operatively of a sacroiliac and thoracolumbar procedure.It was reported that the surgeon felt 1-2 mm off medially with the pedicle needle.The surgeon felt accurate with other instruments and the needle would verify.The site re-spun the patient and were still accurate.There was no delay in the procedure and no impact on patient outcome.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the navigation system functioned as designed.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.

• Brand Name: NAVIGATION STEALTH STATION S7 SYSTEM
• 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: 8549599
• MDR Text Key: 143436977
• Report Number: 1723170-2019-01978
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

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: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 05/30/2019
• Supplement Dates FDA Received: 06/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2013
• 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 Age: 69 YR
• Patient Weight: 109