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

Model Number S7

Device Problems Computer Software Problem (1112); Imprecision (1307)

Patient Problems Spinal Column Injury (2081); Iatrogenic Source (2498)

Event Date 11/09/2016

Event Type  Injury  

Manufacturer Narrative

Patient information was unavailable from the site.A site representative has declined to provide patient information.Initial reported phone number and email address are not available.No parts have been replaced or received back to the manufacturer for evaluation.A software investigation has been initiated, although investigation is not yet complete.

Event Description

A medtronic representative reported that during a spinal fusion procedure, an inaccuracy was alleged against the navigation system.It was reported that at the beginning of the procedure, a 3d scan was acquired using the imaging system.Next, the surgeon verified their instruments and calibrated the instrument tracker to be used with a third party driver and screws.Accuracy was then verified, although an 'abnormality' was noticed.The specifics of this 'abnormality' could not be described by the surgeon.The surgeon made the decision to proceed with the case as planned, and he began placing the first screw.At this point, the surgeon did not feel the screw was being inserted in the correct position, and upon another accuracy check it was discovered that the screw had in fact come out the side of the pedicle.A 1 centimeter inaccuracy was found, in the inferior and lateral (right) directions.After this discovery, a second 3d spin was acquired and accuracy was restored.The procedure was then completed as planned, with no further incident.The alleged malfunction delayed the procedure by less than one hour.No additional details were provided.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment and found the imaging system trackers required re-calibration.After re-calibrating the trackers the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The software investigation found that the symptom was resolved when imaging system trackers were calibrated.Software is functioning as designed.

• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 6155534
• MDR Text Key: 61806115
• Report Number: 1723170-2016-05722
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• 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: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2012
• 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