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

Model Number	POLESTAR
Medical Device Problem Codes	Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return requested.Replacement op sys sw hd drive shipped to site.No parts have been received by manufacturer for analysis.On (b)(6) 2017 a medtronic representative, following-up at the site, reported replaced hard drive.
Event or Problem Description
A site representative reported that, while in a cranial procedure, when trying to connect the navigation system and their surgical mri system, an error message pops up saying that there was no connection with the surgical mri system.No further details regarding this issue, or specifically when it occurred, were provided.The surgeon opted to continue and completed the procedure with the use of the navigation system, however, without the surgical mri system.Delay in therapy was less than one hour.There was no impact on patient outcome.
Additional Manufacturer Narrative
The suspect hard drive was returned to the manufacturer for evaluation.Testing found that corrupted files were present on the hard drive.Additionally bad sectors were discovered.This confirmed a hard drive malfunction as the root cause of the reported issue.

• Brand Name: POLESTAR N30 SURGICAL MRI SYSTEM
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (ISRAEL); p.o. box 548; kochav yokneam bldg.; yokneam elit 20692 ; IS 20692
• MDR Report Key: 6305626
• Report Number: 1723170-2017-00334
• Device Sequence Number: 16157789
• Product Code: LNH
• UDI-Device Identifier: 00613994719225
• UDI-Public: 00613994719225
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K092308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2017

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
• Operator of Device: Physician
• Device Model Number: POLESTAR
• Device Catalogue Number: 9734070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 04/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 65