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

Model Number S7

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site. No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation system during an electrode and probe placement. It was reported that the verification with the imaging system was not successful because merging the scans between the imaging system and the mri failed. All the screws seemed to be misplaced while during navigation. The errors were around. 5mm. The registration of the patient was made by tracer registration. Afterwards, the site noticed that there were bad merges so they continued to trust the previous navigation placement. Once they finished the surgery, the site checked again that the navigation was accurate by touching known anatomical points of the patient's face. The surgery was completed with no delay and with no impact to the patient.

Manufacturer Narrative

Analysis on the software resulted in no failure being found. Analysis states that the software was functioning as designed. 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: lillian lynn ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7665419
• MDR Text Key: 113283054
• Report Number: 1723170-2018-03153
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse