MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 12/30/2017

Event Type  Death  

Manufacturer Narrative

Patient identifier and weight were unavailable from the attached journal article or by the authors.Patient age and patient sex not made available the attached journal article or by the authors.The article reports that the mean patient age was 57.56 and the consisted of male patients in the study.Therefore 58 years old and male were used.The date of death is unknown, so the date of accepted was used.Event date is approximated.Date provided is when the journal article was accepted.Citation: familiari p.Frati a.Pesce a.Et al.Real impact of intraoperative magnetic resonance imaging in newly diagnosed glioblastoma multiforme resection: an observational analytic cohort study from a single surgeon experience.World neurosurg.(2018) 116:e9-e17.Https://doi.Org/10.1016/j.Wneu.2017.12.176.The exact system information could not be determined as it was not provided.However, the system listed on this form was at the address listed in the article during the time some of the surgeries were completed.Device udi not provided as actual product used for this study is unknown.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No further information provided in the journal article or from the authors.The author could not provide any additional information or insight as he was not at the site when the surgeries were performed.No request for service have been received from the customer regarding these events.No parts have been replaced or returned to the manufacturer for evaluation.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's surgical navigation system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

Event Description

The attached journal article was forwarded by medtronic representative.Article indicated the use of surgical navigation system.This is medical device report (mdr) one of two.See 1723170-2018-04203 for the other case.Background: the goal of surgery for brain glioma is to maximize the extent of tumor resection, avoiding postoperative functional impairment.Intraoperative (io) magnetic resonance imaging (mri) has emerged as an effective tool to guide a safer glioma resection.The objective of this study is to assess the real impact of io mri in o-6-methylguanine-dna methyltransferase and non-o-6- methylguanine-dna methyltransferase methylated glioma surgery.Methods: a total of 129 patients suffering glioblastoma who underwent craniotomy for tumor resection were retrospectively evaluated between march 2009 and january 2017 at 2 different affiliated hospitals of the same university.We compared a subgroup of 65 patients operated on without io mri (group a) with medtronic surgical navigation system by a single surgeon (the senior author).Results: the average eor increased from 86.23% 10.51% for group a to 94.01% 7.42% in patients included in group b.The secondary end points of this study were progression-free survival (pfs) and overall survival (os).Pfs was found to be 5.38 2.32 months for group a versus 7.89 2.75 months for group b.Regarding os, the average value was 13.38 4.06 months for group a versus 16.43 3.41 months for group b.-conclusions: we can affirm that 1.5-t io mri is a safe and effective technique, and its use optimizes significantly both the extent of glioma resection and the survival of patients.Reported adverse events hemorrhage: 2 patients in group a, and 2 of 3 patients required surgical revision and 1 of them suffered from a postoperative neurologic vegetative state and died on postoperative day 20 pneumonia: 3 patients, 1 patient died.Myocardial infarction: 1 patient, died.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: koko tyler ; navigation customer quality; 826 coal creek circle; louisville, CO 80027 ; 7208903200
• MDR Report Key: 7806032
• MDR Text Key: 117895557
• Report Number: 1723170-2018-04202
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 58 YR