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Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Muscle Weakness (1967); Visual Impairment (2138); Halo (2227)
Event Date 08/10/2018
Event Type  Injury  
Manufacturer Narrative
Patient age is the mean value of the patients in the study. Patient gender is the majority value of the patients in the study. Patient weight not available from the site. Device lot number, or serial number, unavailable. No parts have been received by the manufacturer for evaluation. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. (b)(4). If information is provided in the future, a supplemental report will be issued.
Event Description
Citation: volker a. Coenen, bastian sajonz, marco reisert, jan bostroem, bettina bewernick, horst urbach, carolin jenkner, peter c. Reinacher, thomas e. Schlaepferb, burkhard mädler, tractography-assisted deep brain stimulation of the superolateral branch of the medial forebrain bundle (slmfb dbs) in major depression. Elsevier, inc. The authors, 2018 2213-1582 background: deep brain stimulation (dbs) of the superolateral branch of the medial forebrain bundle (slmfb) emerges as a - yet experimental - treatment for major depressive disorder (mdd) and other treatment refractory psychiatric diseases. First experiences have been reported from two open label pilot trials in major depression (mdd) and long-term effectiveness for mdd (50 months) has been reported. Objective: to give a detailed description of the surgical technique for dbs of the superolateral branch of the medial forebrain bundle (slmfb) in mdd. Methods: surgical experience from bilateral implantation procedures in n
24 patients with mdd is reported. The detailed procedure of tractography-assisted targeting together with detailed electrophysiology in 144 trajectories in the target region (recording and stimulation) is described. Achieved electrode positions were evaluated based on postoperative helical ct and fused to preoperative high resolution anatomical magnetic resonance imaging (mri; philips medical systems, best, netherlands), including the pre-operative diffusion tensor imaging (dti) tractographic information (stealthviz dti, medtronic, usa; framelink 5. 0, medtronic, usa). Midcommissural point (mcp) coordinates of effective contact (ec) location, together with angles of entry into the target region were evaluated. To investigate incidental stimulation of surrounding nuclei (subthalamic nucleus, stn; substantia nigra, snr; and red nucleus, rn) as a possible mechanism, a therapeutic triangle (tt) was defined, located between these structures (based on mri criteria in t2) and evaluated with respect to ec locations. Results: bilateral slmfb dbs was performed in all patients. We identified an electrophysiological environment (defined by autonomic reaction, passive microelectrode recording, acute effects and oculomotor effects) that helps to identify the proper target site on the operation table. Postoperative mcp-evaluation of effective contacts (ec) shows a significant variability with respect to localization. Evaluation of the tt shows that responders will typically have their active contacts inside the triangle and that surrounding nuclei (stn, snr, rn) are not directly hit by ec, indicating a predominant white matter stimulation. The individual ec position within the triangle cannot be predicted and is based on individual slmfb (tractography) geometry. There was one intracranial bleeding (foresee i study) during a first implantation attempt in a patient who later received full bilateral implantation. Typical oculomotor side effects are idiosyncratic for the target region and at inferior contacts. Conclusion: the detailed surgical procedure of slmfb dbs implantation has not been described before. The slmfb emerges as an interesting region for the treatment of major depression (and other psychiatric diseases) with dbs. So far it has only been successfully researched in open label clinical case series and in 15 patients published. Stimulation probably achieves its effect through direct white-matter modulation of slmfb fibers. The surgical implantation comprises a standardized protocol combining tractographic imaging based on dti, targeting and electrophysiological evaluation of the target region. To this end, slmfb dbs surgery is in technical aspects comparable to typical movement disorder surgery. In our view, slmfb dbs should only be performed under tractographic assistance. Reported events: one instance of intra-operative intracranial bleeding (mer). One hospitalization due to hyperkinesia. One instance of post-operative transient hemiparesis. One instance of post-operative dysarthria. One instance of post-operative hypomania. One instance of post-operative hypertension. One instance of a local infection that was treated with antibiotics. Twenty one reports of blurred vision. Twenty six reports of double vision. Two instances of strabism reported.
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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 Key9197758
MDR Text Key166182419
Report Number1723170-2019-05238
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeGM
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 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2019
Is this an Adverse Event Report? Yes
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 Received09/21/2019
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: 10/16/2019 Patient Sequence Number: 1