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); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Udi not available for this system at time of filing.Device manufacturing date is unavailable at this time.A medtronic representative inspected the system onsite and confirmed the reported issue.The camera cable was replaced and the issue resolved.A full system check-out was completed following part replacement and all tests passed.Full system functionality was confirmed and the system was returned to service.The suspect part has not returned to the manufacturer for evaluation.

Event Description

A medtronic representative reported that while outside of a procedure, there was intermittent camera power/communication failure with the navigation system.While using the system for 10 to 20 minutes the camera shuts down completely and a low beeping sound from the staff cart is heard.There was no patient present when this issue was observed.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacturer date provided.Correction: product and associated fields updated to proper value.

• 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7231519
• MDR Text Key: 98698813
• Report Number: 1723170-2018-00474
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: TK
• 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: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733858
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2015
• 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