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

Model Number S7

Device Problems Device Stops Intermittently (1599); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

The site declined to provide patient information, per (b)(6) privacy laws.Return requested.Replacement emitter shipped to site 11/22/2016.No parts have been received by manufacturer for analysis.On 11/29/2016 a medtronic representative performed a navigation system check-out, software and instruments areas passed.Hardware test failed.The issue was intermittent and due to cable connector at the emitter side.Medtronic representative replaced the emitter and performed system check-out.All tests passed.Issue resolved.Navigation system is fully functional.On 12/07/2016 a medtronic representative, following-up at the site, reported that the cord was somewhat abused, likely from being pulled and held via the cord instead of the heavier emitter itself, thus letting the emitter hang, putting strain on the cord/emitter connection.After the emitter was replaced the navigation system was used in several procedures with issue.

Event Description

A site biomed representative reported that while in a shunt placement procedure, their navigation system experienced intermittent emitter communication.When the cable was manipulated, the surgeon could establish the emitter connection intermittently.The surgeon switched the navigation system to optical, registered the patient with tracer and successfully navigated.The surgeon opted to continue and completed the procedure with the use of the navigation system.Delay in therapy was less than 5 minutes.There was no impact on patient outcome.

Manufacturer Narrative

The suspect emitter was returned to the manufacturer for analysis.The emitter was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• 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 ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6177235
• MDR Text Key: 62466805
• Report Number: 1723170-2016-05766
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2012
• 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