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

Model Number UNK_NAV_SYS

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

Patient Problems Hemorrhage/Bleeding (1888); Neurological Deficit/Dysfunction (1982); Paresis (1998); Seizures (2063); Dysphasia (2195)

Event Date 12/05/2017

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of the patients in the study.Patient sex not available from the site.Patient weight not available from the site.Device lot number, or serial number, unavailable.Additional patient codes include: (b)(4).No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: miran skrap, md, maria caterina vescovi, md, giada pauletto, md, phd, marta maieron, phd, barbara tomasino, phd, daniele bagatto, md, francesco tuniz, md.Supratentorial cavernous malformations involving the corticospinal tract and sensory motor cortex: treatment strategies, surgical considerations, and outcomes.Operative neurosurgery 15:483-497 ,2018.Doi: 10.1093/ons/opx281.Background: cavernous malformations (cms) are congenital malformations and may be located anywhere in the brain.We present a series of cms located close to or inside of themotor-sensory cortex or corticospinal tract (cst)with clinical onset due to hemorrhage or mass effect.In such cases, surgery becomes an acceptable option.Objective: to evaluate the role of diffusion tensor imaging (dti), functional-magnetic resonance imaging (fmri), intraoperative neur ophysiological monitoring, neuronavigation, and brain-mapping and the clinical results of surgical treatment of cms in this critical location.Methods: the study included 54 patients harboring 22 cortical and 32 deep locations.This series was distinct because in group i, where the dti was not obtained, and in the group ii, where this evaluation was performed.Results: the postoperative permanent morbidity rate was 4% in the historical group for the deeper cms, and there was no morbidity in the second group.Dti and fmri permitted us to estimate the distance between the cms and both the cortical activation cluster and the pyramidal tract.These data, in addition to intraoperative mapping and monitoring, made it necessary for us to perform a partial resection in 2 cases in the second series.Conclusion: cms are congenital lesions and cst fibers can run directly on their surface.Integration of fmri and dti data with intraoperative functional monitoring and direct cortical and subcortical mapping are mandatory to accomplish an optimal resection, tailoring the best surgical approach to the acceptable morbidity.A subtotal resection could be considered an option for deep locations.Reported events: 1) bleeding instances occurred in 24 cases.2) recurrent bleeding in 22 cases.3) three cases presented seizures.4) one instance of mass effect with neurological deficits observed in the bleeding instance group.5) three cases of incidental neurological deficits observed.6) 5 instances of severe paresis in the recurrent bleeding group.7) 14 instances of mild hemiparesis in the recurrent bleeding group.8) 2 instances of severe dysphasia in the recurrent bleeding group.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: INSTRUMENT, STEREOTAXIC
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9274475
• MDR Text Key: 167142498
• Report Number: 1723170-2019-05468
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/04/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR