MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. STEALTHSTATION S7 PLANNING STATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7 PLANNING STATION

Device Problems Communication or Transmission Problem (2896); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

A site nurse reported having difficulties saving 3d objects to a universal serial bus (usb) or a cd from stealthviz.In trouble-shooting, a medtronic representative walked through the proper usb mounting process and confirmed usb contents could be seen.Attempt to save to that location was unsuccessful, returned error message: could not write 3d object data file, also displayed an error code.After a system re-boot enable the nurse to write to the usb and to the cd, however, software did not respond as expected with a message confirming transfer complete.When re-launching cranial software, the software would not recognize usb but did recognize cd and images transferred successfully.The medtronic representative walked the nurse through merge and they were able to successfully navigate with tracts.Issue resolved with no delay in the procedure.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

The site declined to provide patient information, referencing canadian privacy laws.On 02/04/2015, a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.On 02/04/2015, following-up at the site, a medtronic representative reported being able to write the stealthviz 3d object to a usb, however, no message was received to confirm the software transfer was successful.Using another computer, the transfer was confirmed.On 02/11/2015, software investigation was completed.This issue was found related to a software issue and was documented in a medtronic software anomaly tracking database.

• Brand Name: STEALTHSTATION S7 PLANNING STATION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: judi ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 4563768
• MDR Text Key: 5472799
• Report Number: 1723170-2015-00249
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2015

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 Model Number: S7 PLANNING STATION
• Device Catalogue Number: 9734048
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2015
• Initial Date FDA Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2013
• 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