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 Hematoma (1884); Muscle Weakness (1967)

Event Date 09/28/2021

Event Type  Injury  

Event Description

Citation: sunil v.Furtado, dravya jayakumar, parichay j.Perikal, and dilip mohan.Contemporary management of distal anterior cerebral artery aneurysms: a dual-trained neurosurgeon's perspective.J neurosci rural pract.2021 oct; 12(4): 711¿717.Published online 2021 sep 28.Doi: 10.1055/s-0041-1735823: 10.1055/s-0041-1735823 abstract: objectives: distal anterior cerebral artery (daca) aneurysms are a subset of aneurysms located in the anterior circulation but away from the circle of willis.We analyze the clinical presentation and outcomes of two treatment groups¿surgical and endovascular¿for daca aneurysms managed by a dual-trained neurosurgeon.Material and methods: a retrospective evaluation of radiological and operative/interventional data of 34 patients with 35 daca aneurysms over a 12-year period was analyzed.Twenty-seven patients underwent surgery, whereas seven underwent endovascular coilingof the aneurysms.Modified fisher grade and world federation of neurosurgical societies scale (wfns) were used to note the subarachnoid hemorrhage (sah) severity.Statistical analysis: categorical data were presented as frequency and percentage, while noncategorical data were represented as mean ± sd.Statistical significance for difference in outcome between the two groups was analyzed using chi-square test, and p 0.05 was considered statistically significant.Results: of 34 patients, 33 presented with a bleed and 23.5% patients were noted to have another aneurysm in addition to the daca aneurysm.Patients who underwent clipping for another aneurysm along with the daca aneurysm in a single surgical exercise had a poor outcome compared with those who underwent surgery for the lone daca aneurysm (7 vs.20, p = 0.015).Most patients in both surgical (70.37%) and endovascular (85.71%) groups had good outcome (mrs = 2).Conclusions: a good outcome can be achieved with either surgery or endovascular coiling in the management of daca aneurysms.In patients with multiple aneurysms, sah with aneurysmal rupture of daca should be managed first; the other unruptured aneurysm may be operated after an interval to avoid morbidity.Reported events: seven patients experienced weakness post-operative nine patients experienced intracerebral hematomas one patient experienced an infraoptic origin of the anterior cerebral artery.

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 online publishing date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon and is 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.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14196646
• MDR Text Key: 294643594
• Report Number: 1723170-2022-00616
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2022

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: 04/18/2022
• Initial Date FDA Received: 04/25/2022
• 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: 49 YR
• Patient Sex: Male