MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems Display or Visual Feedback Problem (1184); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The representative reported that the cpu for the navigation system was replaced after a replacement was shipped to the site.The imaging system then passed the system checkout and was found to be fully functional.No parts have been received by the manufacturer for evaluation.

Event Description

A site representative reported that, while in a cranial resection, when selecting exams on the navigation system the system screen turned blue and became unresponsive.The site representative then restarted the system and the site was able to complete the case.No additional information was provided.There was no impact on patient outcome.

Manufacturer Narrative

Correction: there was a reported delay to the procedure of five minutes due to this issue.Correction to device manufacturing date now provided.The computer was returned to the manufacturer for analysis.The device was found to be fully functional other than being unable to dupe, which was determined not related to reported issue.The reported event could not be duplicated by medtronic personnel.Software review found that the site also leaves the systems on continuously although they have been advised and trained on repeat occasions to discontinue that practice.The event in all of these complaints surrounds an responsive navigation system.A review found that this type of issue was documented in a medtronic navigation software anomaly tracking database for an unresponsive system related to this occurrence.The site has been trained and advised to power down their systems.The computer has also been replaced.Additional information: it was also found by the medtronic representative that the site was not permitted to shut down the system due to the surgeon's instructions.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: oksana ditolla ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 6200348
• MDR Text Key: 63207280
• Report Number: 1723170-2016-05917
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2012
• 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: 47 YR
• Patient Weight: 65