MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9733858

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

Patient Problems Abscess (1690); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426)

Event Date 02/21/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier not available from the site.Patient age is the mean value of patients in the study.Patient gender is the majority value of patients in the study.Patient weight and ethnicity not available from the site.Event date is the accepted date of the publication.Device lot number, or serial number, unavailable.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: ayesha sunil mirchandani, ahmad beyh, jose pedro lavrador, henrietta howells, flavio dell'acqua and francesco vergani.Altered corticospinal microstructure and motor cortex excitability in gliomas: an advanced tractography and transcranial magnetic stimulation study.J neurosurgery.Volume 134.May 2021.Https://thejns.Org/doi/abs/10.3171/2020.2.Jns192994 abstract: objective this prospective case-control study was conducted to examine whether spherical deconvolution (sd) can unveil microstructural abnormalities in the corticospinal tract (cst) caused by idh-mutant gliomas.To determine the significance of abnormal microstructure, the authors investigated the correlation between diffusion parameters and neurophysiological data collected with navigated transcranial magnetic stimulation (ntms).Methods twenty participants (10 patients and 10 healthy controls) were recruited.Diffusion-weighted images were acquired on a 3-t mri scanner using a cardiac-gated single-shot spin echo echo-planar imaging multiband sequence (te 80 msec, tr 4000 msec) along 90 diffusion directions with a b-value of 2500 sec/mm2 (fov 256 × 256 mm).Diffusion tensor imaging tractography and sd tractography were performed with deterministic tracking.The anterior portion of the ipsilateral superior peduncle and the precentral gyrus were used as regions of interest to delineate the cst.Diffusion indices were extracted and analyzed for significant differences between hemispheres in patients and between patient and control groups.A navigated brain stimulation system was used to deliver tms pulses at hotspots at which motor evoked potentials (meps) for the abductor pollicis brevis, first digital interosseous, and abductor digiti minimi muscles are best elicited in patients and healthy controls.Functional measurements such as resting motor threshold (rmt), amplitude of meps, and latency of meps were noted.Significant differences between hemispheres in patients and between patients and controls were statistically analyzed.The spearman rank correlation was used to investigate correlations between diffusion indices and f unctional measurements.Results the hindrance modulated orientational anisotropy (hmoa), measured with sd tractography, is lower in the hemisphere ipsilateral to glioma (p = 0.028).The rmt in the hemisphere ipsilateral to a glioma is significantly greater than that in the contralateral hemisphere (p = 0.038).All measurements contralateral to the glioma, except for the mean amplitude of meps (p = 0.001), are similar to those of healthy controls.Mean diffusivity and axial diffusivity from sd tractography are positively correlated with rmt in the hemisphere ipsilateral to glioma (p = 0.02 and 0.006, respectively).The interhemispheric difference in hmoa and rmt is correlated in glioma patients (p = 0.007).Conclusions sd tractography can demonstrate microstructural abnormality within the cst of patients with idh1-mutant gliomas that correlates to the functional abnormality measured with ntms.Reported events: one patient experienced a post-operative motor deficit (mrc grade 4-5 in the right upper limb) that did not improve by 6 month follow-up.A.It was noted the issue was suspected to be the result of a post-operative abscess that had been surgically drained.Two patients experienced post-operative motor seizures.

• Brand Name: STEALTHSTATION S7
• 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: 11962013
• MDR Text Key: 256457365
• Report Number: 1723170-2021-01516
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050438
• 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: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9733858
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2021
• 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
• Patient Age: 41 YR