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

Model Number S7

Device Problem Imprecision (1307)

Patient Problems Tissue Damage (2104); Brain Injury (2219); Iatrogenic Source (2498)

Event Date 02/05/2016

Event Type  Injury  

Manufacturer Narrative

Patient identifier, age and weight were not made available from the site.Device manufacturing date is unavailable.On 02/11/2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.On 02/16/2016 a medtronic technical services representative, analyzed patient archives and determined that the tracer does not include any defining anatomy and likely contributed substantially to any inaccuracies experienced by the surgeon.Recommended training on proper tracing technique.On 02/18/2016 software investigation completed.Findings are that the tracer pattern is not optimal for an accurate tracer registration.Software is functioning as designed.Determined to be a use error.On 03/05/2016 a medtronic representative, following-up at the site, reported working with the surgeon, detailed recommendations were made regarding improvements for tracer technique to ensure successful trace pattern is accomplished.The medtronic representative observed a subsequent procedure with this surgeon, and following the improved tracing technique, noted satisfactory accuracy.Also noted the 3d model to see if the skin of the patient may have been distorted from positioning devices and cautioned the surgeon to avoid those areas when registering.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A site representative, radiographic technologist (rt), reported on 02/09/2016 that, while in a cranial tumor resection procedure on (b)(6) 2016, the surgeon alleged that their navigation system experienced a 1-3 centimeter inaccuracy.In trouble-shooting, they reported the surgeon did not trace on the patient brow line or on the nose.The surgeon only traced on the spherical portion of the head near the tumor.They reported the surgeon checked accuracy after tracing and felt comfortable, however, after sending a tissue sample to pathology for analysis, the surgeon realized he was not on tumor and had to resect more tissue.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.Two site representatives stated they are unaware of any negative clinical outcome with the patient.

• 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: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 5485012
• MDR Text Key: 39839611
• Report Number: 1723170-2016-00290
• Device Sequence Number: 1
• Product Code: HAW
• 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
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2015
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 98