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

Model Number S7

Device Problem Imprecision (1307)

Patient Problems Headache (1880); Hemorrhage/Bleeding (1888); Iatrogenic Source (2498)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

Event Description

A medtronic representative reported that, while in a cranial biopsy, the surgeon reported difficulty performing a tracer registration.It was reported that the patient was prone with loose skin and thick hair.After three different representatives performed a registration, it was successful.The surgeon the felt the precision was accurate and continued.When in the procedure, the surgeon noted that a hemorrhage occurred within the patient.The procedure was aborted.The computed tomography (ct) then showed that the needle moved contra-lateral to the plan.The surgeon felt that the needle did not skive and the registration was not as accurate than initial.The surgeon was unable to confirm if the needle being off plan was the root cause of the hemorrhage.Following the procedure, the patient experienced a headache.The surgeon noted that they would use fiducials for procedures where the patient has loose skin and coarse hair.There was a reported delay to the procedure of 20 to 30 minutes due to this issue.A medtronic representative reported that the patient was doing well on (b)(6) 2017 and that the imprecision was a few centimeters.A second procedure was not performed and blanket steroids would be used to treat the patient.No additional information was provided.

Manufacturer Narrative

The archive was sent to the manufacturer for evaluation.The evaluation found that the registration technique was not ideal and that the registration showed points sinking into the skin.The registration showed that the patient had excess skin that shifted down when in the prone position.The software investigation found that the reported event was unrelated to a software issue.The software functioned 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 6793649
• MDR Text Key: 82655650
• Report Number: 1723170-2017-03316
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2013
• 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: 53 YR
• Patient Weight: 82