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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
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Brand NameSTEALTHSTATION S7 SYSTEM
Type of DeviceNEUROLOGICAL 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 Key7555315
MDR Text Key109610013
Report Number1723170-2018-02321
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received05/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
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 Received05/16/2018
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 Treatment Data
Date Received: 05/30/2018 Patient Sequence Number: 1
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