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

Catalog Number 9735665

Device Problems Imprecision (1307); Difficult to Open or Close (2921)

Patient Problem Injury (2348)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Device serial number, unavailable at the time of filing.Udi not available for this system at time of filing.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable at this time.No parts have been received by the manufacturer for evaluation.No parts returned for analysis.

Event Description

A manufacturer representative reported an issue with the navigation system.During an electrode and probe placement procedure the leads needed to be revised.The patient was affected.No additional information was available.

Manufacturer Narrative

A manufacturer representative went to the site to test the equipment.It was identified the gantry door was not closing due to misaligned gantry door covers.The gantry doors were realigned and the switches were adjusted.The imaging system then passed the system checkout and was found to be fully functional.No parts were replaced or returned to the manufacturer.

Event Description

A site representative reported that, while outside of a procedure, the imaging system was unable to detect the door was closed intermittently.The button could be held down and the gantry leds would appear and move to their position, but the pendant continued to show door open no matter how long the button was held.Restarting the system allowed the imaging system to register the gantry door as closed.There was no patient present when this issue was identified.

Manufacturer Narrative

Additional information: patient information received.Additional case information received, serial number.Correction: supplemental sequence number one inadvertently filed.Should be under 1723170-2018-00838.

Event Description

Additional information was received from the site.It was reported that the surgeon accepted the placement during the case.The healthcare provider (hcp) could not find an optimum setting due to the side effects at low voltages.At the time of the initial report, the mri follow up was pending to potentially re-do the case.There was a reported delay to the procedure of less than 1 hour due to this issue.No further information was provided.

Manufacturer Narrative

Additional information: device manufacture date provided.Correction: unique device identification (udi) updated to proper value.

Manufacturer Narrative

A software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.

• 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 ; 7635267745
• MDR Report Key: 7352007
• MDR Text Key: 102839713
• Report Number: 1723170-2018-01181
• 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,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 78 YR