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

Model Number S7

Device Problems Imprecision (1307); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348); Iatrogenic Source (2498)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative went to the site to test the equipment.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The issue could not be reproduced.No parts were replaced or returned to the manufacturer for evaluation.

Event Description

A site representative reported that, while in a spinal fusion procedure there was an alleged inaccuracy after screw placement.The imaging system showed different screw placement than the navigation system's screen.It was reported that the spinous process clamp had been placed too far away from the operating field.There was a reported delay to the procedure of less than 1 hour due to this issue and no impact on the patient outcome.No additional information was provided.

Manufacturer Narrative

Additional information: a medtronic representative reported that the imprecision was 3 millimeters.It was reported that the screw was revised as a result of the imprecision.Correction: adverse event fields updated to proper value.The software investigation found that the reported event was unrelated to a software issue.The software functioned as designed.

Manufacturer Narrative

Patient information was provided by the site.

• 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: divinemercy bakare ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7218794
• MDR Text Key: 98307584
• Report Number: 1723170-2018-00392
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169505742
• UDI-Public: 00643169505742
• Combination Product (y/n): N
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733858
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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: 85 YR
• Patient Weight: 68