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

Model Number S7

Device Problems Mechanical Problem (1384); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Output Problem (3005)

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

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to site to test the equipment.Representative reported that a polaris spectra system control unit (scu)to positioning sensor unit (psu) cable was replaced.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect cable has been received by the manufacturer for evaluation.The returned cable was found to be in good condition and passed continuity test with no opens.No fault found.

Event Description

A site representative reported that during cranial resection, the camera of the navigation system would intermittently switch to localizer not connected.Site was able to get the system to a good position and complete the case.During troubleshooting, representative checked connections.When the localizer disconnected the lights on the camera stays on.Checked the cable for cuts but could not reproduce the issue.Camera arm was moved.Ndi toolbox showed no errors.The procedure was completed with the use of navigation.There was no delay to procedure.No known impact on patient outcome.

Manufacturer Narrative

Other relevant device(s) are: product id: 9733575, serial/lot #: (b)(4), ubd: unknown, udi# unknown.The device codes are now applicable upon further review.If information is provided in the future, a supplemental report will be issued.

• 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: prashanth gali ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7397554
• MDR Text Key: 104412211
• Report Number: 1723170-2018-01444
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• 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: 03/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2012
• 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: 60 YR
• Patient Weight: 59