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

Model Number S7

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Loss of Vision (2139)

Event Date 03/29/2017

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 37.9 years old and the consisted of male patients in the study.Therefore 38 years old and male were used.Event date is approximated.Date provided is when the journal article was accepted.Citation: xin wang, md, long li, md, yibao wang, phd et al.Clinical application ofmultimodal neuronavigation system in neuroendoscope-assisted skull base chordoma resection.The jornal of craniofacial surgery 2017; 28:6 e554-e557 doi: 10.1097/scs.0000000000003859 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.Multiple attempts have been made to obtain additional information.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.Per author, integration of endoscopy with multimodal neuronavigation is beneficial in the surgical treatment of skull base chordomas, and significantly improves total resection rate and reduces postoperative complications.This navigation system combining multiple imaging modalities and 3d reconstruction provides an optimal way to recognize specific skull base anatomical and adjunct neurovascular structures.Additionally, intraoperative ultrasound and neurophysiological monitoring also represent efficient and inexpensive tools for intraoperative imaging and surgical guidance.It suggests that the multimodal neuronavigation system may become a standard tool for planning and guidance of skull base surgery.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.Not returned by customer.

Event Description

The attached journal article was forwarded by medtronic representative.Article indicated the use of surgical navigation system.A total of 93 patients who underwent skull base chordoma resection at (b)(6) hosp were enrolled from january 2012 to january 2016.Forty-five patients underwent endoscopic surgical resection with assistance of the multimodal neuronavigation system, and the other 48 patients underwent the traditional transnasal endoscopic approach without imaging guidance (control group).There were 52 men (55.9%) and 41 women (44.1%), male/female ratio 1.27:1, the age range of the patients was 22 to 68 years, with a mean age of 37.9 years.Due to the precise identification of vital neurovascular structures, no patients in the neuronavigation group had radiographically identified bleeding, and only 1 had temporary reduced vision, which improved after symptomatic treatment.In each group, 1 patient had cerebrospinal fluid leakage, although the symptoms improved markedly after lumbar drainage for 3 to 5 days.All patients in the neuronavigation underwent tumor resection with the assistance of the multimodal neuronavigation system recovered without recurrence.

• 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: 7555315
• MDR Text Key: 109610013
• Report Number: 1723170-2018-02321
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 38 YR