MAUDE Adverse Event Report: MEDTRONIC NAVIGATION ISRAEL POLESTAR N-30 SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number POLESTAR N30

Device Problems Computer Software Problem (1112); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Response, Decreased (2271); Iatrogenic Source (2498)

Event Date 06/30/2014

Event Type  Injury  

Event Description

A medtronic representative reported that during a cranial tumor resection procedure using the polestar n-30 scanner software version 1.8.0, the software behaved in a way that the surgeon did not expect.Prior to the first scan being taken the starshield was closed, then the patient angles were set in the software.The software then had a pop-up message which asked whether the patient, or the magnet, had moved.The user selected "no." instead of storing the initial scan position as the surgeon expected, the software did not record the position.The magnet was lowered and the surgeon proceeded with surgery.When going back for a second scan, the system did not have the initial scan position stored and subsequently, both the "go-to-scan-position" and "adjust-to-table" buttons were inactive.The surgeon claimed that this prevented him from being able to compare the two scans properly.Surgery was completed and the surgeon closed the patient.The surgeon reported that after reviewing a 2 day post-op scan, unintended residual tumor was detected.

Manufacturer Narrative

Although residual tumor was found, a medtronic representative, following-up at the site, reported that the patient has not had or been scheduled for another surgery.The surgeon did not indicate there would be another surgery performed.Software investigation was completed.This issue was documented in a medtronic software anomaly tracking database.Engineering analysis found that the described event relates to the polestar motion control feature, enabling automated magnet positioning for scan with reference to the patient position.The event occurs only for a starshield configuration and following a very specific chain of actions (i.E.Changing patient angles while the starshield is extended and answering "no" to the prompted question asking about gantry or patient movement.) as the "go to scan position" and "adjust to table" features are disabled the user must manually guide the magnet to its desired scanning position.Logs and images from the case were analyzed and the following conclusions were determined: a software anomaly did happen in this case and prevented the user from automatically positioning the magnet back into the desired position.The user was able to manually guide the magnet to a position very close to the one previously defined and was able to verify positioning using imaging.There was no limitation on magnet positioning and the user was able to verify proper positioning and adjust it per his discretion.It is thus concluded that the described event is not directly related to the reported software anomaly.The manufacturing site's analysis is that use error contributed to the residual tumor.No parts have been returned to manufacturer for analysis.

• Brand Name: POLESTAR N-30 SYSTEM
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): MEDTRONIC NAVIGATION ISRAEL; p.o. box 548; kochav yokneam bldg.; yokneam elit, 2069 2; IS 20692
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: catherine eaton ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902092
• MDR Report Key: 4153458
• MDR Text Key: 4766369
• Report Number: 1723170-2014-01047
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K092308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: POLESTAR N30
• Device Catalogue Number: 9734070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2011
• 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): Other
• Patient Age: 41 YR
• Patient Weight: 86