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Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Meningitis (2389)
Event Date 12/10/2018
Event Type  Injury  
Manufacturer Narrative
Patient information was unavailable from the site. Event date is the accepted date of the publication. Device lot number, or serial number, unavailable. Pma/510(k) is dependent upon the product number, therefore the value is unavailable. No parts have been received by the manufacturer for evaluation. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. Additional fdp codes: c50672, c50579, c50487. If information is provided in the future, a supplemental report will be issued.
Event Description
Citation: robert e. Gross, md, phd; edward k. Sung, md, patrick mulligan, md; nealen g. Laxpati, md, phd; darlene a. Mayo, md; and john d. Rolston, md, phd. Accuracy of frameless image-guided implantation of depth electrodes for intracranial epilepsy monitoring. J neurosurg 132: 681-6901, 2020. Https://thejns. Org/doi/abs/10. 3171/2018. 12. Jns18749 objective: various techniques are available for stereotactic implantation of depth electrodes for intracranial epilepsy monitoring. The goal of this study was to evaluate the accuracy and effectiveness of frameless mri-guided depth electrode implantation. Methods: using a frameless mri-guided stereotactic approach (stealth), depth electrodes were implanted in patients via burr holes or craniotomy, mostly into the medial temporal lobe. In all cases in which it was possible, postoperative mr images were coregistered to planning mr images containing the marked targets for quantitative analysis of intended versus actual location of each electrode tip. In the subset of mr images done with sufficient resolution, qualitative assessment of anatomical accuracy was performed. Finally, the effectiveness of implanted electrodes for identifying seizure onset was retrospectively examined. Results: sixty-eight patients underwent frameless implantation of 413 depth electrodes (96% to medial temporal structures) via burr holes by one surgeon at 2 institutions. In 26 patients (203 electrodes) planning and postoperative mr images were available for quantitative analysis; an additional 8 procedures with 19 electrodes implanted via craniotomy for grid were also available for qualitative analysis. The median distance between intended target and actual tip location was 5. 19mm (mean 6. 19 + 4. 13mm, ranged <(><<)>2mm-29. 4mm). Inaccuracy for transtemporal depths was greater along the electrode (i. E. , deep), and posterior, whereas electrodes inserted via an occipital entry deviated radially. Failure to localize seizure onset did not result from implantation inaccuracy, although 2 of 62 patients (3. 2%) - both with electrodes inserted occipitally - required reoperation. Complications were mostly transient, but resulted in long-term deficit in 2 of 68 patients (3%) conclusions: despite modest accuracy, frameless depth electrode implantation was sufficient for seizure localization in the medial t emporal lobe when using orthogonal approach, but may not be adequate for occipital trajectories. Reported events: three patients experienced infections following burr hole depth electrode implantation surgeries one was noted to be an intracranial abscess, two were noted to be meningitis, one patient experienced a parenchymal hemorrhage of the left temporal lobe. The hemorrhage was suspected to contribute to a persistent verbal memory deficit. One patient experienced a significant subdural hematoma from depth electrode implantation through burr holes, requiring surgical evacuation without sequelae. Two patients experienced transient neurological deficits without specific etiology. Five patients experienced cerebrospinal fluid (csf) drainage or pseudomeningocele after depth electrode implantation. Two cases of postoperative wound infection were observed.
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Manufacturer (Section D)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key10225501
MDR Text Key199711398
Report Number1723170-2020-01767
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2020
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 Received06/07/2020
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: 07/02/2020 Patient Sequence Number: 1