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

Model Number S7

Device Problem No Display/Image (1183)

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

Event Date 09/19/2016

Event Type  malfunction  

Manufacturer Narrative

The initial report occurred on (b)(6) 2016 and was found to be a non-reportable malfunction based on the information available at the time the event occurred.On 01/17/2017, a retrospective review related to a capa was completed for all events where the reported malfunction was not previously associated with serious injuries; the reporting determination has been revised to consider these malfunction events reportable.Patient information was unavailable from the site.Device manufacturing date is unavailable.Onsite investigation was preformed and suspected that the surgeon monitor along with its cable caused the reported event.Replacement of the monitor and the cable resolved the issue.No further issues were reported.Analysis of the returned cable could not confirm any failure as it passed bench testing and functioned as intended.Analysis of the returned monitor confirmed an electrical failure as the issue was reproduced during testing.A full system check-out was completed and all tests passed.Full system functionality was confirmed and the system was returned to service.

Event Description

A medtronic representative reported that while in a cranial biopsy procedure, the navigation system's surgeon monitor went black.The surgeon proceeded with using the staff monitor for the rest of the surgery.There was no reported delay to the procedure due to this issue.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: sam saleh ; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 6321991
• MDR Text Key: 67229486
• Report Number: 1723170-2017-00639
• 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,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• 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: 01/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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