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

Model Number S7

Device Problem Image Display Error/Artifact (1304)

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

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the video splitter was defective.The field service engineer (fse) replaced the splitter and the system began functioning as intended.The system then passed the system checkout and was found to be fully functional.

Event Description

Medtronic received information regarding a navigation system.It was reported pre-operatively during equipment set-up for a sacroiliac and thoracolumbar procedure, the system had no signal and both monitors were black.The site had used the system for a previous procedure and had no issues.The system was turned off in between the procedures.When the patient was in the or, the system was turned on to perform the 2nd surgery but there was no signal and black screen on both monitors.The site rebooted the system without resolution.The site confirmed that the main power was plugged in correctly.The site also confirmed that the uninterruptible power supply (ups) output power was correct.There was over one hour delay.The surgery was aborted.

Manufacturer Narrative

The lcd surgeon touchscreen monitor was returned to the manufacturer for analysis.Analysis found that was unable to duplicate the reported issue as the monitor displayed a good image, but the touch function worked intermittently.Analysis found that the reported event was related to a electrical issue.The system's computer was also returned to the manufacturer, however, analysis results are not yet available.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The computer rollingstone embedded was returned to the manufacturer for analysis.Per analysis, no fault was found.If information is provided in the future, a supplemental report will be issued.

• 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: maxwell roth ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7857644
• MDR Text Key: 119646679
• Report Number: 1723170-2018-04454
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2012
• 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
• Patient Age: 49 YR
• Patient Weight: 66