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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Muscle Weakness (1967)
Event Date 08/22/2019
Event Type  Injury  
Manufacturer Narrative
Patient weight not available from the site. Event date is the accepted date of the publication. Device lot number, or serial number, unavailable. 510(k) is unavailable as the value is dependent on serial number and product id. No parts have been received by the manufacturer for evaluation. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Citation: sahar farhat, houssein darwish, wassim nasreddine, joseph salame, ahmad beydoun. A surgical case of complete resection of the focal cortical and subcortical dysplasia in the motor cortex. World neurosurgery, 2019, 132. Https://doi. Org/10. 1016/j. Wneu. 2019. 08. 1. Background: focal cortical dysplasias (fcds) are highly epileptogenic and frequently associated with medically refractory focal epilepsy. Fcds are frequently located in the frontal lobe, making its complete resection highly challenging when in proximity to the motor cortex. Case description: we report a case of a (b)(6)-year-old woman with medically refractory epilepsy secondary to a focal cortical dysplasia in the motor cortex and extending deeply into the subcortical white matter. A detailed presurgical evaluation and invasive electroencephalographic monitoring performed at our epilepsy monitoring unit, along with the use of motor mapping, functional magnetic resonance imaging, diffusion tensor imaging, and the stealth navigation system resulted in the complete resection of the lesion without a permanent postoperative motor deficit. The patient remained seizure-free at a 63-month follow-up while being maintained on a single antiepileptic drug. Conclusion: a detailed presurgical evaluation, accurate mapping of the functional and dysplastic cortex, and a well-planned tailored and complete surgical resection of the cortical dysplasia can result in a favorable outcome with relatively little risk of postoperative neurologic deficit. Reported event: the patient experienced a mild transient left central facial weakness with full motor power in their extremities. The event was reported to have resolved at their three month follow-up.
 
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Brand NameMEDTRONIC NAVIGATION
Type of DeviceINSTRUMENT, STEREOTAXIC
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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10680325
MDR Text Key211840604
Report Number1723170-2020-02703
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeLE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK_NAV_SYS
Device Catalogue NumberUNK_NAV_SYS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2020
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: 10/14/2020 Patient Sequence Number: 1
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