MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SYS 9734070 POLESTAR N30 SURGICAL MRI; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 9734070

Device Problems Poor Quality Image (1408); Radiofrequency Interference (RFI) (2314); Patient Device Interaction Problem (4001)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

Udi not available for this system at time of filing.The device was not returned, so no analysis was conducted.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device used for a cranial resection procedure.The issue occurred intraoperatively and delayed the surgery by less than one hour.It was reported that the site has an issue with the system during the surgery.The system home position was not working and they had to restart the system.Then, when they were able to perform the scan, the noise level was very high and the image quality was very bad.So then, they performed a second scan and the image quality improved, but they got a shimming calibration error.The surgery was completed without imaging or navigation and there was no impact on patient outcome.

Manufacturer Narrative

Additional information: a medtronic representative (mr) analyzed the system log and the conclusion was that the high noise and low signal were cause by operator's mistake.Daily qa was performed on (b)(4) 2019 according to the mr's suggestion, and the results were like the successful pm of (b)(6) 2018 and unlike the results reported in the complaint.Hence, the case is closed as operation mistake.If information is provided in the future, a supplemental report will be issued.

Event Description

(b)(4) (hcp, rep, for) medtronic received information regarding a navigation device used for a cranial resection procedure.The issue occurred intraoperatively and delayed the surgery by less than one hour.It was reported that the site has an issue with the system during the surgery.The system home position was not working and they had to restart the system.Then, when they were able to perform the scan, the noise level was very high and the image quality was very bad.So then, they performed a second scan and the image quality improved, but they got a shimming calibration error.The surgery was completed with imaging and navigation and there was no impact on patient outcome.A medtronic representative (mr) analyzed the system log and the conclusion was that the high noise and low signal were cause by operator's mistake.Daily qa was performed on (b)(4) 2019 according to the mr's suggestion, and the results were like the successful pm of (b)(6).2018 and unlike the results reported in the complaint.Hence, the case is closed as operation mistake.

Manufacturer Narrative

Patient information was unavailable from the site.Correction: the patient information provided was incorrect and the correct patient demographics are unavailable from the site.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYS 9734070 POLESTAR N30 SURGICAL MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8358225
• MDR Text Key: 136762980
• Report Number: 1723170-2019-00745
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9734070
• Device Catalogue Number: 9734070
• Device Lot Number: WO081102440190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 70