MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (ISRAEL) POLESTAR N30 SURGICAL MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number POLESTAR

Device Problems Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

Patient weight not made available from the site.On 06/09/2016 a medtronic representative performed a navigation system check-out, all areas passed.When the medtronic representative arrived on site, the system was already on.It was not possible to move the mouse or to use the keyboard.System hard re-boot restored normal function.Issue resolved.System performed as intended.No parts were replaced.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A site physician reported that, while in a cranial procedure, their navigation system software became unresponsive.After performing scan, 3d data were not visible.Re-loading patient and session was not possible.No images were visible.At this point the cranial software became unexpectedly unresponsive and displayed a blue screen.During the procedure, experienced the software being very slow and some windows would not close properly.The surgeon opted to discontinue the use of the navigation system and the imaging system to continue the procedure to completion.Delay in therapy was less than one hour.There was no impact on patient outcome.

Manufacturer Narrative

A medtronic representative reported that he talked with the surgeon.She completed the surgery with the ct-scans using another navigation system.The tumor was removed and the patient is in good condition.The hardware investigation of the returned computer found that the reported event was related to a software issue.The problem that occurred on site was that the images were not refreshing during scrolling the images up and down.The hard disk drive (hdd) was replaced with another nominal hdd unit and the reported problem was solved.The returned hdd was checked and the following was found: the problem that images were not refreshing during scrolling the images up and down was able to be duplicated.The sub software called ¿prserver¿ (¿off the shelf product¿) that is integrated in the polestar software is responsible for the system images refreshing.During hdd performance test (using windows tool), it was found that the hdd functionality is comply ¿ no bad sectors and no physical damage.It was identified that a software anomaly failure in the sub software ¿prserver¿ was the cause of the problem in the hdd leading to the images not refreshing.The reported event was confirmed.The software investigation concurred that the reported event was related to a software issue.A rep replaced the primary hard disk drive (hdd) to resolve the reported issue.

• Brand Name: POLESTAR N30 SURGICAL MRI SYSTEM
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (ISRAEL); p.o. box 548; kochav yokneam bldg.; yokneam elit 20692 ; IS 20692
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (ISRAEL); p.o. box 548; kochav yokneam bldg.; yokneam elit 20692 ; IS 20692
• Manufacturer Contact: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 5775499
• MDR Text Key: 48974431
• Report Number: 1723170-2016-01337
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K092308
• 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
• Report Date: 08/08/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: POLESTAR
• Device Catalogue Number: 9734070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR