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Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Hematoma (1884); Unspecified Infection (1930); Nausea (1970); Pain (1994); Skin Irritation (2076); Vomiting (2144); Depression (2361)
Event Date 06/15/2015
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 accepted date of the publication. Device lot number, or serial number, unavailable. 510(k) is dependent upon and is therefore, 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: (b)(4). If information is provided in the future, a supplemental report will be issued.
Event Description
Citation: francisco a. Ponce, wael f. Assad, kelly d. Foote, william s. Anderson, g. Rees cosgrove, gordon h. Baltuch, kara beasley, donald e. Reymers, esther s. Oh, steven d. Targum, gwenn s. Smith, constantin. Bilateral deep brain stimulation of the fornix for alzheimer's disease: surgical safety in the advance trial. J neurosurgery, 2016, 125, http://thejns. Org/doi/abs/10. 3171/2015. 6. Jns15716 abstract: objective: this report describes the stereotactic technique, hospitalization, and 90-day perioperative safety of bilateral deep brain stimulation (dbs) of the fornix in patients who underwent dbs for the treatment of mild, probable alzheimer¿s disease (ad). Methods: the advance trial is a multicenter, 12-month, double-blind, randomized, controlled feasibility study being conducted to evaluate the safety, efficacy, and tolerability of dbs of the fornix in patients with mild, probable ad. Intraoperative and perioperative data were collected prospectively. All patients underwent postoperative mri. Stereotactic analyses were performed in a blinded fashion by a single surgeon. Adverse events (aes) were reported to an independent clinical events committee and adjudicated to determine the relationship between the ae and the study procedure. Results: between june 6, 2012, and april 28, 2014, a total of 42 patients with mild, probable ad were treated with bilateral fornix dbs (mean age 68. 2 ± 7. 8 years; range 48. 0¿79. 7 years; 23 men and 19 women). The mean planned target coordinates were x
5. 2 ± 1. 0 mm (range 3. 0¿7. 9 mm), y
9. 6 ± 0. 9 mm (range 8. 0¿11. 6 mm), z
-7. 5 ± 1. 2 mm (range -5. 4 to -10. 0 mm), and the mean postoperative stereotactic radial error on mri was 1. 5 ± 1. 0 mm (range 0. 2¿4. 0mm). The mean length of hospitalization was 1. 4 ± 0. 8 days. Twenty-six (61. 9%) patients experienced 64 aes related to the study procedure, of which 7 were serious aes experienced by 5 patients (11. 9%). Four (9. 5%) patients required return to surgery: 2 patients for explantation due to infection, 1 patient for lead repositioning, and 1 patient for chronic subdural hematoma. No patients experienced neurological deficits as a result of the study, and no deaths were reported. Conclusions: accurate targeting of dbs to the fornix without direct injury to it is feasible across surgeons and treatment centers. At 90 days after surgery, bilateral fornix dbs was well tolerated by patients with mild, probable ad. Reported events. One patient underwent prolonged hospitalization due to headaches on post-operative day 1. Nausea and vomiting were noted on day 2. Three patients experienced dermatological events including bruising, dermatitis and rash. Six patients experienced fatigue. 6 patients experienced gastrointestinal issues including nausea and vomiting. 3 patients experienced urinary retention. 12 patients experienced headaches. 3 patients experienced pain/discomfort in the neck/shoulder/mastoid. One lead was reported to have been misplaced. One patient experienced a chronic & subacute hematoma. One patient experienced an infection. Five patients experienced mental status changes including confusion, delirium and depression.
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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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key10774862
MDR Text Key215885400
Report Number1723170-2020-02862
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 11/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2020
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 Received10/23/2020
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: 11/02/2020 Patient Sequence Number: 1