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

Model Number S7

Device Problems Computer Software Problem (1112); Imprecision (1307); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

Patient weight not available from the site.No parts have been received by the manufacturer for evaluation.Part not returned for analysis.

Event Description

A site representative reported that, while in a lead placement procedure, it was reported that the leads were placed more laterally than planned in the application software of the navigation system.A confirmation image acquisition on a medtronic imaging system showed that the leads were on the lateral parallel trajectory.It was noted that the leads remained at their placed location as the patient was unharmed from the reported issue.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.No additional information was provided.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.It was reported that the issue could be replicated alongside two separate medtronic imaging systems.

Manufacturer Narrative

Additional information: software analysis results.The software logs were returned to the manufacturer for analysis.Known anomaly determination was conducted.Testing found that this behavior is consistent to test track (b)(4).References to this case have been added to that record.No further action required.

Manufacturer Narrative

A software analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7252088
• MDR Text Key: 99803915
• Report Number: 1723170-2018-00593
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 02/27/2018; 08/22/2018; 06/21/2019
• Supplement Dates FDA Received: 03/13/2018; 09/07/2018; 07/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2015
• 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: 57 YR