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

Model Number 9735665

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

Patient Problems Pain (1994); Unspecified Nervous System Problem (4426)

Event Date 09/26/2022

Event Type  malfunction  

Event Description

D¿ercole, m., izzo, a., silvestri, m., olivi, a., tufo, t.Percutaneous balloon compression for treatment of trigeminal neuralgia assisted by o-arm o2-based navigation: case series and review of the literature.Operative neurosurgery.2022.23 (464¿471) https://d oi.Org/10.1227/ons.0000000000000395.Background: percutaneous cannulation of foramen ovale (fo) for treatment of trigeminal neuralgia, classically performed according to empirical landmarks and under fluoroscopic guide, may be difficult, time-consuming, and burdened with vascular or neurological complications related to close anatomic relationships.Objective: to investigate cannulation of fo for treatment of trigeminal neuralgia assisted by o-arm o2-based navigation, to assess safety and accuracy.Methods: nineteen patients underwent percutaneous balloon compression of gasserian ganglion assisted by navigation provided by o-arm o2 and stealthstation.Clinical outcomes according to barrow neurological institute pain score, time of recurrence, side effects, and complications, as well as technical aspects as time of the procedure and number of tracks were investigated and evaluated.Obtained data were compared with current literature in a systematic review.Results: the median time for procedure was 46 minutes; cannulation of the fo was performed in a median of 3 minutes and 47 seconds, in a single track in 16 patients, while 3 cases required a further o-arm acquisition to check the needle position.No complications were observed.Onset of facial hypoesthesia was recorded in 10 patients and dysesthesia in 5.Although at a median follow-up of 12.7 months 7 patients had recurrence after an average pain-free period of 7.3 months, all but 2 patients had improvement in pain score.Conclusion: advantages powered by navigation should be addressed in accuracy, lower complication rate, and success of cannulation even in case of previous treatments or anatomic variations, rather than in effective reduction of surgical time.Reported events: 3 cases with difficult access, a further o-arm acquisition was necessary to obtain an intraoperative check of the needle position.5 patients showed a worsening of pain dysesthesia was associated to hypoesthesia in 5 patients, all with a prolonged pain history and other previous treatments.Facial pain occurred in 3 patients.2 patients referred onset of contralateral trigeminal neuralgia.

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

• 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: 16005825
• MDR Text Key: 308557463
• Report Number: 1723170-2022-02095
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/11/2022
• Initial Date FDA Received: 12/19/2022
• 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: 66 YR
• Patient Sex: Female