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 Hematoma (1884); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Visual Disturbances (2140); Cognitive Changes (2551); Unspecified Nervous System Problem (4426)

Event Date 01/14/2022

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 publishing 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

Duff, j.M., omoumi, p., bobinski, l., belouaer, a., wuthrich, s.P., zanchi, f., maduri, f.Transtubular image-guided surgery for spinal intradural lesions: techniques, results, and complications in a consecutive series of 60 patients.J neurosurg spine 37:121¿129.Doi: 10.3171/2021.10.Spine211168 objective the authors previously described the image merge tailored access resection (imtar) technique for resection of spinal intradural lesions (sidls).The authors reported their updated experience with the imtar technique and compared surgical results between patients who underwent operations with 2d or 3d fluoroscopic guidance.Methods the authors reviewed 60 patients who underwent sidl resection with transtubular techniques over a 14-year period.The earlier patients in the series underwent operations with 2d fluoroscopic image guidance.The latter patients underwent operations with the imtar technique based on 3d image guidance.The results of both techniques were analyzed.Results sixty patients were included: 27 females (45%) and 33 males (55%).The median (range) age was 50.5 (19¿92) years.Gross-total resection (gtr) was achieved in 52 patients (86.7%).Subtotal resection was accomplished in 5 patients (8.3%).Neurological complications occurred in 3 patients (5%), and tumor recurrence occurred in 1 patient (1.7%).The non-imtar and imtar cohorts showed similar postoperative nurick scale scores and rates of neurological complications and gtr.The median (interquartile range) bone resection surface area at the index level was 89.5 (51¿147) mm2 in the non-imtar cohort and 35.5 (11¿71) mm2 in the imtar cohort, with a statistically significant difference (p = 0.0112).Conclusions surgery for sidls may be challenging, and meticulous surgical planning is crucial to optimize tumor access, maximize res ection, and minimize risk of complications.Image-guided transtubular resection is an additional surgical technique for sidls and facilitates microsurgical tumor removal of ventrally located lesions with a posterolateral approach, without requiring potentially des tabilizing bone resection.Reportable events local complications occurred in 5 patients (8.3%).Three patients presented with superficial wound infections that were treated with wound care and oral antibiotics.1 patient presented with a subcutaneous hematoma that resolved spontaneously.1 patient with the wrong level at the cervicothoracic junction was exposed, which required extension of the surgical exposure for tumor resection and a subsequently longer operative time.General medical complications, only 1 patient (1.7%) presented with transient delirium related to medications.Neurological complications occurred in 3 patients (5%).One patient with a c6¿7 meningioma had worsened right triceps weakness that improved at follow up.Postoperative horner¿s syndrome after resection of an extraforaminal c8 root schwannoma occurred in 1 patient.1 patient presented with dysesthesias in the distribution of the right l3 nerve root that were controlled with gabapentin at follow-up.No complications were related to midline placement of the reference frame, and the impact of postoperative pain was minimal owing to limited tissue dissection.See attached literature article.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15217409
• MDR Text Key: 305277119
• Report Number: 1723170-2022-01281
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K050438
• 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: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 08/03/2022
• 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: 51 YR
• Patient Sex: Male