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

Model Number S7

Device Problem Insufficient Information (3190)

Patient Problems Loss of Vision (2139); Meningitis (2389); No Code Available (3191)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

Patient identifier and weight were unavailable from the attached journal article or by the authors. Patient age and patient sex not made available the attached journal article or by the authors. The article reports that the mean patient age was 10. 7 and the consisted of female patients in the study. Therefore 11 years old and female were used. Event date is approximated. Date provided is when the journal article was published. Citation: fohlen m, ferrand-sorbets s, delalande o. Et al. Surgery for subependymal giant cell astrocytomas in children with tuberous sclerosis complex. (2018). Child's nervous system (2018) 34:1511¿1519 https://doi. Org/10. 1007/s00381-018-3826-6 the exact system information could not be determined as it was not provided. However, the system listed on this form was at the address listed in the article during the time some of the surgeries were completed. Device udi not provided as actual product used for this study is unknown. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. No further information provided in the journal article or from the authors. The author could not provide any additional information or insight as he was not at the site when the surgeries were performed. No request for service have been received from the customer regarding these events. No parts have been replaced or returned to the manufacturer for evaluation. Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's surgical navigation system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event. (b)(4) not returned by customer.

Event Description

The attached journal article was forwarded by medtronic representative. Article indicated the use of surgical navigation system. Objective : subependymal giant cell astrocytomas (segas) are low-grade intraventricular glial tumors that develop in 10¿15%of patients with tuberous sclerosis complex; they often cause hydrocephalus and are potentially accessible to a surgical treatment. Our aim is to evaluate morbidity and results after surgery in symptomatic and asymptomatic patients. Method we present a retrospective series of 18 pediatric patients operated on for sega between 2006 and 2016 at our institution. We reviewed surgical indications, preoperative clinical and radiologic data, surgical management, and clinical and radiological follow-up. Results mean age at surgery was 10. 7 years. The surgical decision was based on clinical signs of raised intracranial pressure due to hydrocephalus in 8 and on radiological findings without any clinical signs in the other 10 patients (increased in segavolume with or without ventricular enlargement). Surgical treatment consisted in a frontal trans-ventricular microsurgical approach in 17 patients and an endoscopic approach in 1. External ventricular drainage was placed in all the patients but 1. Ventriculoperitoneal shunting (vps) became necessary in 6 patients, all of them presenting with a preoperative active hydrocephalus. Morbidity appeared very low with meningitis occurring in 1 patient. Resection was complete in 15 children with no recurrence during a mean follow-up of 5. 25 years and incomplete in 3 requiring a second surgery. Conclusion surgery of sega represents a very effective treatment with low morbidity and no mortality in the present series. In patients operated before the onset of clinical signs of hydrocephalus, internal vps could be avoided whereas in others, an additional shunt surgery became necessary. This gives arguments in favor of a regular mri surveillance in tuberous sclerosis complex patients with sega in order to best propose resective surgery once a growth of tumor and/or ventricular size have been confirmed but before raised intracranial pressure occurs. Reported adverse event patient, sex, age, (b)(6). Patient 1 f 10. 4 epilepsy not resolved ; patient 2 m 13. 6 epilepsy not resolved, residual growing lesions ; patient 3 f, 1. 1 epilepsy not resolved ; patient 6 m 5. 6 epilepsy not resolved ; patient 7 m 21 presented with permanent visual loss due to progressive optic nerve atrophy, epilepsy not resolved patient 9 epilepsy not resolved ; patient 8 f 1 meningitis, residual growing lesions ; patient 10 f 22. 7 epilepsy not resolved ; patient 11 m 9. 7 epilepsy not resolved ; patient 12 m 12 epilepsy not resolved ; patient 14 f 6. 2 epilepsy not resolved ; patient 15 f 7. 5 epilepsy not resolved ; patient 16 m 8 epilepsy not resolved ; patient 17 m 7. 7 epilepsy not resolved ; patient 18 f 17. 6 epilepsy not resolved.

• 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: koko tyler ; navigation customer quality; 826 coal creek circle; louisville, CO 80027 ; 7208903200
• MDR Report Key: 7805894
• MDR Text Key: 117897202
• Report Number: 1723170-2018-04201
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 08/22/2018 Patient Sequence Number: 1