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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Weakness (1967); Rupture (2208); Brain Injury (2219)
Event Date 09/28/2021
Event Type  Injury  
Event Description
Furtado, s. V. , jayakumar, d. , perikal, p. J. , mohan, d. (2021). Contemporary management of distal anterior cerebral artery aneurysms: a dual-trained neurosurgeon's perspective. Journal of neurosciences in rural practice, 12(04), 711¿717. Https://doi. Org/10. 1055/s-0041-1735823. Summary: 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 coiling of 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 si gnificance 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 event: thirty-four patients with a histology of daca aneurysms underwent surgery or endovascular coiling. In four cases, there was an aneurysm rupture during dissection and was controlled by application of a proximal clip, and then further continuation of aneurysm neck dissection and clipping. Post-operatively, seven patients developed weakness. Two of these cases were due to vasospasms, and one patient had a right frontal venous infarct and superior mesenteric artery(sma) syndrome. Five patients also had retraction associated with frontal contusion, which did not require any further intervention.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameMEDTRONIC NAVIGATION
Type of DeviceNEUROLOGICAL 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 Key14104857
MDR Text Key289224535
Report Number1723170-2022-00555
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
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
Date Manufacturer Received04/05/2022
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 Treatment Data
Date Received: 04/13/2022 Patient Sequence Number: 1
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