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

Model Number S7

Device Problems Imprecision (1307); Calibration Problem (2890)

Patient Problem Iatrogenic Source (2498)

Event Date 09/08/2017

Event Type  Injury  

Manufacturer Narrative

Patient identifier field not sufficient to hold all digits, should read: (b)(6).Patient weight not available from the site.A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.It was reported that the navigation system and imaging system were later used in a separate procedure with no allegation of deficiency.It was noted that the imaging system was found to be out of calibration following the reported issue and that calibrating the imaging system restored functionality to the system.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts were replaced, therefore no parts were returned for analysis.

Event Description

A site representative reported that, while in a deep brain stimulation (dbs) procedure, an imprecision of 5.1 millimeters was observed.The surgeon noted that all directions were imprecision and with the anterior direction being the most inaccurate.A non-sterile imaging system image acquisition was used to navigate to the entry point.Once the mer electrode was placed, a confirmation image acquisition was performed to create an entry and a new plan for the target point.The surgeon reported that the difference between the two locations was 5.1 millimeters.The surgeon then removed the microelectrode, repeated the same process and found that the surgeon was within 1.5 millimeters of the plan.All images were then merged and found that the trajectory was properly aligned.A medtronic representative reported that no new burr hole was needed for the procedure and that the trial lead was misplaced.The permanent lead was placed without issue.There was a reported delay to the procedure of 45 minutes due to this issue.No additional information was provided.

Manufacturer Narrative

Additional information: per cross-functional site review, it was determined there was an accidental radiation occurrence.A review of the dose report found that the patient received a minimal radiation dose of 0.791322 msv with no reported impact.

Manufacturer Narrative

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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 6925771
• MDR Text Key: 88736627
• Report Number: 1723170-2017-03981
• 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
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 76