MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number UNK_NAV_SYS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Cerebrospinal Fluid Leakage (1772); Hemorrhage/Bleeding (1888); Unspecified Nervous System Problem (4426)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

Patient age not available from the site.Patient sex not available from the site.Patient weight not available from the site.The event date is the online published date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent on the device model number and is therefore unavailable.No parts have been received by the manufacturer for evaluation.Device manufacture date is dependent on the device lot/serial number, therefore is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: jihwan yoo, hun ho park, in-sik yun, chang-ki hong.Clinical applications of the endoscopuic transorbital approach for various lesio ns.Acta neurochirurgica (2021) 163:2269-2277.Https://doi.Org/10.1007/s00701-020-04694-y abstract: background: the endoscopic transorbital approach (etoa) was recently added to the neurosurgical armamentarium.Although this approach could result in less injury to normal brain tissue, shorter operation times, and smaller scars, its clinical applications have not been fully investigated.We, therefore, sought to share our unique experiences of exploring the application of this approach in various diseases.Methods: from june 2017 to march 2019, we conducted etoas via the superior eyelid crease in 22 patients for the treatment of lesions confined to the middle fossa with and without slight extension to the posterior fossa.These lesions included 5 gliomas, 11 meningiomas, 3 schwannomas, 1 lymphoma, 1 cavernous hemangioma in the orbital wall, and 1 hemangiopericytoma mimicking schwannoma.Perioperative radiologic findings and clinical outcomes were recorded.Results: gross total resection was accomplished in three (60%) patients with gliomas, nine (81.8%) with meningiomas, two (66.7%) with schwannomas, and one (33.3%) with another lesion.The mean bleeding count was 1051.4 ± 961.1 cc, and major complications were observed in only two (9.1%) cases (one major cerebral artery infarction and one reoperation due to a large amount of bleeding).A cerebrospinal fluid leak was reported in two (9.1%) patients, and transient eye movement palsy was noted in four (18.2%) patients without permanent disability.Conclusions: the endoscopic transorbital approach could be considered to be feasible for various lesions with different characteristics.After carefully considering the lesion anatomy, consistency, and vascular relationships, using this approach, we could achieve a satisfactory extent of resection without severe complications.Reported events: one major cerebral artery infarction was observed.One re-operation due to blood loss was observed.Two patients experienced a cerebrospinal fluid (csf) leak.Four instances of transient eye movement palsy were noted without permanent disability.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12388551
• MDR Text Key: 269499417
• Report Number: 1723170-2021-02166
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention