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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Muscle Weakness (1967); Unspecified Nervous System Problem (4426)
Event Date 07/01/2021
Event Type  Injury  
Manufacturer Narrative
Patient age is the mean value of patients in the study. Patient gender is the majority value of patients in the study. Patient weight not available from the site. Event date is the online publishing date of the literature article. Device lot number, or serial number, unavailable. 510(k) is dependent upon the device model number and is therefore, unavailable. No parts have been received by the manufacturer for evaluation. Device manufacture date is dependent on the device lot/serial number, therefore is unavailable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Voets, n. L. , pretorius, p. , birch, m. D. , apostolopoulos, v. , stacey, r. , plaha, p. Diffusion tractography for awake craniotomy: accuracy and factors affecting specificity. Journal of neuro-oncology (2021) 153:547¿557. Https://doi. Org/10. 1007/s11060-021-03795 introduction: despite evidence of correspondence with intraoperative stimulation, there remains limited data on mri diffusion tractography (dt)¿s sensitivity to predict morbidity after neurosurgical oncology treatment. Our aims were: (1) evaluate dt against subcortical stimulation mapping and performance changes during and after awake neurosurgery; (2) evaluate utility of early post-operative dt to predict recovery from post-surgical deficits. Methods: we retrospectively reviewed our first 100 awake neurosurgery procedures using dt- neuronavigation. Intra-operative stimulation and performance outcomes were assessed to classify dt predictions for sensitivity and specificity calculations. Post-operative dt data, available in 51 patients, were inspected for tract damage. Results: 91 adult brain tumor patients (mean 49. 2 years, 43 women) underwent 100 awake surgeries with subcortical stimulation between 2014 and 2019. Sensitivity and specificity of pre-operative dt predictions were 92. 2% and 69. 2%, varying among tracts. Post-operative deficits occurred after 41 procedures (39%), but were prolonged (>3 months) in only 4 patients (4%). Post-operative dt in general confirmed surgical preservation of tracts. Post-operative dt anticipated complete recovery in a patient with supplementary motor area syndrome, and indicated infarct-related damage to corticospinal fibers associated with delayed, partial recovery in a second patient. Conclusions: pre-operative dt provided very accurate predictions of the spatial location of tracts in relation to a tumor. As expected, however, the presence of a tract did not inform its functional status, resulting in variable dt specificity among individual tracts. While prolonged deficits were rare, dt in the immediate post-operative period offered additional potential to monitor neurological deficits and anticipate recovery potential. Reportable events: in four patient there were minor wounds leaks/infections five patient had persisting deficits which were transient one patient had persisting motor sma syndrome one patient had residual lower limb weakness.
 
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Brand NameMEDTRONIC NAVIGATION
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 Key12599442
MDR Text Key278073635
Report Number1723170-2021-02462
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUK
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 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2021
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 Received10/04/2021
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: 10/08/2021 Patient Sequence Number: 1
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