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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 Insufficient Information (3190)
Patient Problems Cerebrospinal Fluid Leakage (1772); Facial Nerve Paralysis (1846); Hemorrhage/Bleeding (1888)
Event Date 01/05/2018
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 59 and the consisted of female patients in the study. Therefore 59 years old and female were used. Event date is approximated. Date provided is when the journal article was accepted. Citation: shin m. Shojima m. Kondo k. Et al. Endoscopic endonasal craniofacial surgery for recurrent skull base meningiomas involving the pterygopalatine fossa, the infratemporal fossa, the orbit, and the paranasal sinus. (2018). World neurosurg. (2018) 112:e302-e312. Https://doi. Org/10. 1016/j. Wneu. 2018. 01. 041. 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.
 
Event Description
The attached journal article was forwarded by medtronic representative. Article indicated the use of surgical navigation system. Objective: skull base meningiomas carry a nonnegligible risk of recurrence. In particular, those arising from the sphenoid wings or middle cranial fossa penetrate into extracranial regions, uncommonly showing massive expansion into the craniofacial regions on recurrence. The role of endoscopic endonasal surgery for those intractable lesions remains unclear. Methods: we performed endoscopic endonasal craniofacial surgery for 8 recurrent meningiomas invading into the pterygopalatine fossa, infratemporal fossa, nasopharynx, paranasal sinus, or orbit, comprising 2 meningothelial and 1 fibrous meningiomas (world health organization [who] grade i), 3 atypical and 1 clear cell meningiomas (grade ii), and 1 anaplastic meningioma (grade iii). All were large (15e80 cm3; median, 45 cm3) and highly vascularized. Results: all 8 tumors were sufficiently resected. Gross total resection of the craniofacial part of the lesions was achieved in 5 patients (62. 5%). In 3 patients with who grade i meningiomas and 1 with grade ii, tumors were successfully controlled as of the last follow-up. In 4 patients with who grade ii or iii meningiomas, craniofacial lesions were controlled, whereas original intracranial lesions were poorly controlled and became critical. Conclusions: we consider the endoscopic endonasal approach as an acceptable, less-invasive alternative for recurrent craniofacial meningioma. Although all these cases were relatively large and highly vascularized, preoperative endovascular embolization of the feeding arteries contributes to significantly reducing vascularity of the tumors, and local control of the craniofacial lesions was successfully achieved in all cases. Endoscopic endonasal craniofacial surgery enabled sufficient mass reduction without disfiguring facial incisions. Reported adverse event: a (b)(6) male surgical intervention due to significant blood loss with initial resection. A (b)(6) female showed numbness of facial sensation with dry eye, resolved within 3 months. A (b)(6) male intracranial lesion was poorly controlled, csf dissemination. A (b)(6) female intracranial lesion was poorly controlled, csf dissemination. A (b)(6) female intracranial lesion was poorly controlled.
 
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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 Key7782745
MDR Text Key117136369
Report Number1723170-2018-04052
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
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 08/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2018
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 Received08/01/2018
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: 08/14/2018 Patient Sequence Number: 1
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