MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9735665

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Communication or Transmission Problem (2896); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device manufacturing date is unavailable.A medtronic representative went to site to test the equipment.Representative reported that navigation system was not communicating with imaging system.Network cable was replaced to resolve the issue.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect cable has not been received by the manufacturer for evaluation.

Event Description

A site representative reported that during spinal fusion procedure, the navigation system became unresponsive when loading exams.It was reported that the navigation system had a communication issue with imaging system due to a bad network cable.Switching the cable resolved the issue.When typing on the touch screen, the system was not recognizing the touch.Rebooting the issue resolved the issue.The procedure was completed with the use of navigation.There was no delay to procedure.No known impact on patient outcome.

Manufacturer Narrative

Correction: common device name, part number, and unique device identification (udi) updated to proper value.Additional information: device manufacture date provided.

Manufacturer Narrative

A software analysis was initiated to determine the probable cause of the issue through known anomaly determination.Analysis found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.

Manufacturer Narrative

The fda codes were updated to reflect the current coding guidelines.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S8 PREMIUM 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7427442
• MDR Text Key: 105443571
• Report Number: 1723170-2018-01603
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/21/2019

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: Physician
• Device Catalogue Number: 9735665
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 04/13/2018; 06/19/2018; 06/19/2018
• Supplement Dates FDA Received: 05/07/2018; 07/12/2018; 06/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2017
• 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 Age: 68 YR
• Patient Weight: 95