MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9735665

Device Problem Imprecision (1307)

Patient Problems Blurred Vision (2137); Twitching (2172); Dizziness (2194); Dysphasia (2195); Dyskinesia (2363); Shaking/Tremors (2515); Paresthesia (4421)

Event Date 06/25/2022

Event Type  malfunction  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patient in the study.Patient weight not available from the site.Event date is the online accepted date of the literature article.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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Sánchez-gómez, a., camargo, p., cámara, a., roldán, p., rumià, j., compta, y., carbayo, á., martí, m.J., muñoz, e., valldeoriola, f.Utility of postoperative imaging software on dbs targeting in patients with movement disorders.World neurosurgery.2022 https://do i.Org/10.1016/ j.Wneu.2022.06.132.Objective: to evaluate the accuracy of the suretune3 postoperative imaging software in determining the location of deep brain stimulation (dbs) electrode based on clinical outcomes and the adverse effects (aes) observed.Methods: twenty-six consecutive patients with parkinson¿s disease (pd, n=17), essential tremor (et, n=8) and dystonia (n=1) that underwent bilateral dbs surgery (52 electrodes) were included in this study.Pre-surgical assessments were performed in all patients prior to surgery, and at three and six months after surgery, using quality-of-life (qol) and clinical scales in each case.The suretune3 software was used to evaluate the anatomical positioning of the dbs electrodes.Results: following dbs surgery, motor and qol improvement was observed in all patients.Different aes were detected in 12 patients, in 10 of whom (83.3%) suretune3 related the symptoms to the positioning of an electrode.A clinical association was observed with suretune3 for 48/52 (92.3%) electrodes, whereas no association was found between the aes or clinical outcomes and the suretune3 reconstructions for 4/52 electrodes (7.7%) from four different patients.In two patients the contact chosen was modified based on the suretune3 data and in two cases, the software helped determine that second electrode replacement surgery was necessary.Conclusions: the anatomical position of electrodes analyzed with suretune3 software was strongly correlated with both the aes and cl inical outcomes.Thus, suretune3 may be useful in clinical practice, and it could help improve stimulation parameters and influence decisions to undertake electrode replacement surgery.Reportable events: mri confirmed the misplacement of the electrodes 12 reported different immediate or subacute aes.Suretune3 confirmed electrode misplacement in ten of these (83.3%) 4 patient with an immediate side effect of blurred vision 14 patient with an immediate side effect of transient paresthesia 1 patient with an immediate side effect of facial twitching and dysarthria 1 patient with an immediate side effect of paresthesia plus mild dysarthria in dorsal contacts 1 patient with an immediate side effect of dizziness, paresthesia and blurred vision 1 patient with an immediate side effect of dysarthria >2ma 1 patient with an immediate side effect of dysarthria >3ma 1 patient with an immediate side effect of dysarthria plus phosphenes >2ma 1 patient with subacute side effect and remaining symptoms of choreic-ballistic dyskinesia in the lower left limb 1 patient with subacute side effect and remaining symptoms of ballistic choreic dyskinesia in the lower right limb 4 patient with subacute side effect and remaining symptoms of disinhibition 1 patient with subacute side effect and remaining symptoms of dysarthria and tremors 1 patient with subacute side effect and remaining symptoms of mild tremors 2 patient with subacute side effect and remaining symptoms of minimal dysarthria 1 patient with the electrode placed medially 1 patient with the electrode placed slightly ventral and medial 1 patient with the electrode placed slightly ventral 1 patient with the electrode placed slightly medial 3 patient with the electrode placed ventral and medial 1 patient with the electrode placed slightly dorsal 1 patient with the electrode placed ventral 2 patient with the electrode placed slightly anterior.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• 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: 15322406
• MDR Text Key: 305508911
• Report Number: 1723170-2022-01402
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K162309
• 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: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• 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 Age: 61 YR
• Patient Sex: Male