MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number TREON

Device Problems Failure to Transmit Record (1521); Communication or Transmission Problem (2896); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

A medtronic representative reported that, while in a lumbar fusion spine procedure, using a navigation system and an o-arm imaging system, two spins had been previously transferred successfully.The third spin transferred only a partial data set, not all images were found.In trouble-shooting, they tried manually pushing the images, swapping network cables and re-booting.This was unsuccessful as when the exam was pushed, the navigation system remained on receiving exam and did not change.The surgeon attempted another spin with the same result.The medtronic representative recommended they check the hard drive space which showed 100 per cent full.Deleting exams from the hard drive, re-booting the software and manually pushing the exam from the o-arm resolved the issue.The exam transferred successfully and the surgery proceeded as planned.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Medtronic representative, trouble-shooting during the event, resolved the issue by identifying the hard-drive was 100 percent full.An appropriate amount of patient files were deleted to free-up hard-drive space, allowing the procedure to continue after a system re-boot.The procedure was completed successfully with no further issues.There have been no reports of problems, or concerns, with this navigation system following this event.

• Brand Name: STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
• 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: 3620790
• MDR Text Key: 4159362
• Report Number: 1723170-2014-00121
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/14/2014

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: TREON
• Device Catalogue Number: 9680111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2014
• Initial Date FDA Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2007
• 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: 60 YR
• Patient Weight: 109