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Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Muscle Weakness (1967); Visual Impairment (2138); Complaint, Ill-Defined (2331); Post Operative Wound Infection (2446)
Event Date 01/17/2019
Event Type  Injury  
Manufacturer Narrative
Patient information was not included in the journal article. This value is the mean age of the patients in the article as specific patients could not be identified. This value reflects the gender of the majority of the patients in the article as specific patients could not be identified. Please note that this date is based off of the date the article was available as the event dates were not provided in the published literature. Article citation is included. System product number and serial number not provided in journal article. Udi not available for this system. No 510k provided as system is unknown. No evaluation was performed as this event was reported in literature. Device manufacturing date is unavailable. If information is provided in the future, a supplemental report will be issued.
Event Description
Citation: jia-sheng pei, peng-fan yang, qiao lin, yan-zeng jia, hui-jian zhang, ming-chao shang, zhong-hui zhong, shou-sen wang, neuronavigati on-assisted surgical treatments for medically refractory epilepsy: single-hospital experience with 4 surgical approaches, clinical neurology and neurosurgery, volume 182, 2019, pages 148-151, issn 0303-8467, https://doi. Org/10. 1016/j. Clineuro. 2019. 01. 010. Summary: objective: surgical treatment should be considered for patients with medically refractory epilepsy, and neuronavigation may benefit and reduce the technical difficulties during surgery. In this study, we aimed to report our single-hospital experience of incorporating neuronavigation for treating patients with medically refractory epilepsy using 4 types of surgery. Patients and methods: patients who were diagnosed as medically refractory epilepsy and received neuronavigation- assisted surgery were included in this retrospective analysis. The type of surgery was decided by the surgery committee after careful evaluation and discussion, including temporo-parietal-occipital (tpo) disconnection, anterior subtotal callosal section, functional hemispherectomy and resection of the epileptogenic zone(s). Postoperative seizure outcome at the last visit was evaluated using engel classification. Results: a total of 173 patients with medically refractory epilepsy who were treated surgically under the assistance of neuronavigation were included. The majority type of surgery was resection of epileptic zone, n
104 (60. 12%). An excellent seizure outcome, engel class i was found in 50. 86% of the patients, followed by 23. 12% patients with a good outcome of engel class ii. Conclusion: overall more than half of the patients could have excellent seizure outcome of engel class i, the postoperative complications were manageable. These results indicated that the applicability of neuronavigation, and the use of neuronavigation provides good efficacy and safety for all kinds of surgical procedures for patients with medically refractory epilepsy. The navigation system was used for preoperative planning and intraoperative guidance. Anatomical marker points (e. G. Nasal, orbital and auricular points) or if not available i. E. Prone position, 5¿7 external fiducial markers were applied to the scalp for registration. Acquired images were transferred onto the workstation and a 3d model of the patient was reconstructed. After general anesthesia, the patient¿s head was placed in a non-medtronic three-point head fixation system, the dynamic reference frame was attached to the clamp, the anatomic or scalp fiducials were used for registration. The navigation system then estimated the accuracy of the mathematical match between the scan and physical space. If the error was larger than 2 millimeters, registration and calibration should be carried out again. Reported events: twenty-three patients who underwent tempro-parietal-occipital disconnection had contralateral visual field defect. Two patients who underwent tempro-parietal-occipital disconnection had cerebral edema and one needed craniotomy to remove the swelling tissue. One patient who underwent tempro-parietal-occipital disconnection had incision infection and surgical debridement was required. Eighteen patients who underwent anterior subtotal callosal section had disconnection syndromes. All were resolved within three weeks. Seven patients who underwent functional hemispherectomy had decreased muscle strength in contralateral extremities. Five patients recovered to preoperative levels within six months. Two patients still had decreased muscle strength in the left extremities. One patient who underwent resection of epileptic zone had decreased muscle strength in the left upper extremities. One patient with cerebral cavernous malformations had incision infection and recovered after oral administration of antibiotics.
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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 Key9026489
MDR Text Key162516489
Report Number1723170-2019-04866
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2019
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 Received08/16/2019
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: 09/13/2019 Patient Sequence Number: 1