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Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Tissue Damage (2104)
Event Date 12/30/2019
Event Type  Injury  
Manufacturer Narrative
Patient age is the mean value of patients in the cohort. Patient gender is the majority value of patients in the cohort. Patient weight not available from the site. Event date is the accepted date of the publication. 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. 510(k) is dependent on the model number of the product. Therefore, 510(k) is unavailable. If information is provided in the future, a supplemental report will be issued.
Event Description
Citation: yarema b. Bezchlibnyk, vibhash d. Sharma, kushal b. Naik, faical isbaine, john t. Gale, jennifer cheng, shirley d. Triche, nicholas m. Boulis, stewart a. Factor, thomas wichmann, mahlon r. Delong, and robert e. Gross. Clinical outcomes of globus pallidus deep brain stimulation for parkinson disease: a comparison of intraoperative mri- and mer-guided lead placement. J neurosurg march 6, 2020 doi: 10. 3171/2019. 12. Jns192010 objective: deep brain stimulation (dbs) lead placement is increasingly performed with the patient under general anesthesia by surgeons using in reoperative mri (imri) guidance without microelectrode recording (mer) or microstimulation. The authors assessed the accuracy of lead placement, safety, and motor outcomes in patients with parkinson disease (pd) undergoing dbs lead placement into the globus pallidus internus (gpi) using imri and mer guidance. Methods: the authors identified all patients with pd who underwent either mer or imri guided gpi-dbs lead placement at emory university between july 2007 and august 2016. Lead placement accuracy and adverse events were determined for all patients. Clinical outcomes were assessed using the unified parkinson's disease rating scale (updrs) part iii motor scores for patients completing 12 months of follow-up. The authors also assessed the levodopa-equivalent daily dose (ledd) and stimulation parameters. Results: seventy-seven patients were identified (mer, n
28; imri, n
49), in whom 131 leads were placed. The stereotactic accuracy of the surgical procedure with respect to the planned lead location was 1. 94 + 0. 21mm (mean + sem) (85% cl 1. 54-2. 34) with frame-based mer and 0. 84 _ 0. 0007 mm (95% cl 0. 69-0. 98) with imri. The rate of serious complications were similar at 6. 9% for mer-guided dbs lead placement with 9. 4% for imri-guided dbs lead placement (rr 0. 71 [95% cl 0. 13-3. 9%]; p
0. 695). Fifty-seven patients were included in clinical outcome analyses (mer, n
16; imri, n
41). Both groups had similar characteristics at baseline, although patient undergoing mer-guided lead placement (25. 5% + 6. 7% [95% cl, 33. 2%-56. 4%] versus 61. 6% + 2. 1% [85% cl 57. 4%-65. 8%]; t
3. 558, p
0. 001). Greater improvement was seen following imri-guided lead placement (43. 2% + 3. 5% [95% cl 36. 2%-50. 3%]) versus mer-guided lead placement (25. 5% + 6. 7% [95% cl 11. 1%-39. 8%]; f
5. 835, p
0. 019). When updrs iii motor scores were assessed only in the contralateral hemibody (per-lead) analyses), the improvements remained significantly different (37. 1% + 7. 2% [95% cl 22. 2%-51. 9%] and 50. 0% + 3. 5% [95% cl 43. 1% - 56. 9%] for mer and imri guided dbs lead placement, respectively). Both groups exhibited similar reductions in ledds (21. 2% and 20. 9% respectively; f
0. 221, p
0. 640). The locations of all active contacts and the 2d radial distance from these to consensus coordinates for gpi-dbs lead placement (x, +20; y, +2; and z, -4) did not differ statistically by type of surgery. Conclusion: imri-guided gpi-dbs lead placement in pd patients was associated with significant improvement in clinical outcomes, comparable to those observed following mer-guided dbs lead placement. Furthermore, imri-guided dbs implantation produced a similar safety profile to that of the mer-guided procedure. As such, imri guidance is an alternative to mer guidance for patients undergoing gpi-dbs implantation for pd. Reported events: (b)(6) yr male experienced an infection requiring explantation of unilat dbs lead, extension and ipg. (b)(6) yr female experienced an infection requiring explantation of unilat dbs lead, extension and ipg. (b)(6) yr male experienced revision of unilat lead with imri-dbs. (b)(6) yr male experienced revision of unilat lead with imri-dbs. (b)(6) yr male experienced revision of unilat lead with imri-dbs.
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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 Key10148966
MDR Text Key195528848
Report Number1723170-2020-01653
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 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
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: 06/12/2020 Patient Sequence Number: 1