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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7¿ NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7¿ NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9733856
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Hydrocephalus (3272); Convulsion/Seizure (4406)
Event Date 09/12/2021
Event Type  Injury  
Event Description
Citation: zhang, c. , ge, h. , zhang, s. Et al. Hematoma evacuation via image-guided para-corticospinal tract approach in patients with spontaneous intracerebral hemorrhage. Neurol ther 10, 1001¿1013 (2021). Https://doi. Org/10. 1007/s40120-021-00279-8 summary: introduction: corticospinal tract injury caused by direct hematoma compression and secondary damage induced from blood toxic substances might influence the outcomes in patients with intracerebral hemorrhage (ich). This study aimed to evaluate the safety and efficacy of hematoma evacuation via image guided para-corticospinal tract approach based on the protection of compressed or residual corticospinal tract. Methods: seventy-five patients with ich who underwent the image-guided para-corticospinal tract approach were retrospectively collected into the surgery group. Diffusion tensor imaging or computed tomography angiography was performed to identify the relationship between important white matter tracts and hematoma. The neuronavigation system for the preoperative imaging data loaded was used to identify the location of the burr hole, insertion trajectory, and depth of insertion. Cortical entry points and insertion trajectories were kept parallel to the corticospinal tract route into the hematoma based on the protection of compressed or residual corticospinal tract. Hematoma was removed under the image-guided para-corticospinal tract approach. (b)(6) age-, sex-, hematoma site-, and volume-matched patients with ich who underwent conservative treatment were selected as controls. Demographical, clinical, radiological, and treatment-related data were retrospectively analyzed. Functional outcome was evaluated by modified rankin scale on day 90. Results: a total of 150 patients with ich were retrospectively enrolled. The median glasgow coma scale (gcs) score on admission was 11 (iqr 8¿13). Deep hematoma (thalamus and basal ganglion) was present in 86. 7% (130 patients). The mean hematoma volume on admission was 47 ± 19 ml, and the postoperative hematoma volume was 11 ± 10 ml. A higher proportion of favorable outcome was observed in the surgery group than in conservative treatment group (32. 0% versus 17. 4%; p
=
0. 037). Conclusion: hematoma evacuation via image guided para-corticospinal tract approach based on the protection of compressed or residual corticospinal tract seems to be safer in patients with ich with a relatively higher functional independence. Reported event: 51 patients in the surgery group had unfavorable outcomes 62 patients in the conservative treatment group and unfavorable outcomes 4 patients in the surgery group had hydrocephalus 5 patients in the conservative treatment group had hydrocephalus 61 patients in the surgery group had pneumonia 54 patients in the conservative treatment group had pneumonia 7 patients in the surgery group had gi bleeding 6 patients in the conservative treatment group had gi bleeding 18 patients in the surgery group had hematoma expansion 13 patients in the conservative treatment group had hematoma expansion 2 patients in the surgery group had intracranial infection 5 patients in the surgery group had seizures 1 patient in the conservative treatment group had seizures.
 
Manufacturer Narrative
Patient information was not included in the journal article. This value reflects the mean age of the patients in the article as specific patients could not be identified. This value reflects the gender of the majority of the patients in the article specific patients could not be identified. Please note that this date is based off of the date the article was published online as the event dates were not provided in the published literature. Article citation is included. System serial number not provided in journal article. Udi not available for this system. No evaluation was performed as this event was reported in literature. Device manufacturing date is unavailable. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTEALTHSTATION® S7¿
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12933641
MDR Text Key281744798
Report Number1723170-2021-02813
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9733856
Device Catalogue Number9733856
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? No
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: 12/06/2021 Patient Sequence Number: 1
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