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

Model Number S7

Device Problems Device Displays Incorrect Message (2591); Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

On 07/27/2016 software investigation completed.Findings are that there was no software anomaly.There was no issue with the navigation system.Software is functioning as designed.

Event Description

A medtronic representative reported that, while in a spine procedure, the site was unable to activate their empty image.The site received and error message stating that the image quality was poor.The medtronic representative reported that the image looked to be of good quality.In trouble-shooting, the navigation system was re-booted, the video cable was changed and adjusted their image technique.Another c-arm was brought in to continue the procedure.After bringing in a different ge 9800 c-arm, the site was able to take an activate on empty.At this point, the surgeon had finished the procedure without navigation.There was no delay in therapy as the surgeon continued working while others were troubleshooting.This was an issue with the c-arm.There was no impact on patient outcome.

• 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: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 5845771
• MDR Text Key: 51114412
• Report Number: 1723170-2016-02018
• Device Sequence Number: 1
• Product Code: HAW
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2014
• 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: 63 YR
• Patient Weight: 77