MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9735665

Device Problem Imprecision (1307)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

Continuation of concomitant medical products: product id: 9735740, software version: 1. 2. 0, ubd: unknown, udi#: unknown. No products have been returned to medtronic for analysis. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used during a sacroiliac and thoracolumbar procedure. It was reported that there was an alleged inaccuracy. One level case, two screws were put it in and were accurate. Saved reverse projections off the navigated pedicle access kit (pak) needle. The left side was accurate. The right side was inaccurate while starting to tap l4. The axial appeared accurate, and the other views were off. An x-ray was performed to confirm the area where the surgeon was tapping was accurate. It just appeared inaccurate in trajectory 2, synthetic lateral, and probes eye navigation views. This issue occurred intra-operatively and caused a surgical delay of less than one hour. There was no impact on patient outcome.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13026034
• MDR Text Key: 286647901
• Report Number: 1723170-2021-02913
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse