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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 Problem Muscle Weakness (1967)
Event Date 04/25/2018
Event Type  Injury  
Manufacturer Narrative
Patient identifier and weight were unavailable from the 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 21. 9 and the consisted of male patients in the study. Therefore 22 years old and male were used. Event date is approximated. Date provided is when the journal article was accepted. Citation: li z. Wang m. Zhang l. Et. Al. Neuronavigation-guided corticospinal tract mapping in brainstem tumor surgery: better preservation of motor function. World neurosurg. (2018) 116:e291-e297. Https://doi. Org/10. 1016/j. Wneu. 2018. 04. 189. 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. 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
Objective: to evaluate a new technique in brainstem surgery, neuronavigation (nn)-guided corticospinal tract (cst) mapping, in a retrospective study of patients undergoing brainstem tumor surgery. Methods: we studied 40 patients with a brainstem tumor who were enrolled in this study. Patients whose worst preoperative muscle strength of the 4 limbs was greater than 3 levels from normal on the lovett scale were divided into 2 groups: a treatment group of 21 patients who underwent nn-guided cst mapping and routine intraoperative neurophysiology monitoring (ionm) and a control group of 19 patients who underwent routine nn and ionm. Preoperative muscle strength and postoperative (day 90 postsurgery) muscle strength were assessed and compared between the 2 groups. Results: in the nn-guided cst mapping group, 3 patients (14. 3%) had a decrease in muscle strength by 1 level postoperatively, and no patient experienced a decrease of >1 level. In the control group, 4 patients (21. 1%) had a 1-level decrease in muscle strength, and 5 (26. 3%) had a decrease of >1 level. Patients in the nn-guided cst mapping group had significantly better surgical outcomes compared with those in the control group (p [ 0. 018, fisher exact test). Conclusions: brainstem tumor resection using nnguided cst mapping achieved better preservation of motor function compared with routine nn and ionm. Nnguided cst mapping not only decreased the difficulty of the surgery, but also significantly improved the efficiency of surgery. Author stated no complications were observed in relation to the nn-guided cst mapping, either intraoperatively or postoperatively. Reported adverse event declined muscle strength: 4 patients in control group experienced a decline in muscle strength in 1 level; 5 patient in control group experienced a decline in muscle strength over 1 level.
 
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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 Key7805692
MDR Text Key117889030
Report Number1723170-2018-03865
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 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
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 Received08/16/2018
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: 08/22/2018 Patient Sequence Number: 1
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