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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problem Insufficient Information (3190)
Patient Problems Cerebrospinal Fluid Leakage (1772); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Visual Impairment (2138); No Code Available (3191)
Event Date 12/30/2017
Event Type  Injury  
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. 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. Journal article. Not returned by customer.
 
Event Description
The journal article was forwarded by medtronic representative. Article indicated the use of surgical navigation system. This is medical device report (mdr) two of two. See 1723170-2018-04202 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. Csf disturbance: 2 patients in group a, and 1 patient in group a developed a surgical cavity infection which required surgical revision. 3 of 4 patients were managed surgically, resolved. Pneumonia: 3 patients, 1 patient died. Myocardial infarction: 1 patient, died. Kidney failure: 1 patient. Motor deficit: 6 patients in group a presented a new or worsening of a pre-existing motor deficit. Within 11 patients total, 9 of them presented a minor transient impairment which resolved within 30 days postoperatively. Two of 11 cases the deficit was permanent. Speech disturbance: 6 cases of new or worsening pre-existing speech disturbancs. One improved at 30 days, 3 were stable at follow-up, 2 completely resolved within 30 days visual field deficits: 2 patients, permanent at follow-up. Vegetative state patient: 1 patient.
 
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Brand NameSTEALTHSTATION S7 SYSTEM
Type of DeviceNEUROLOGICAL 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 Key7846362
MDR Text Key119238643
Report Number1723170-2018-04203
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2018
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 Treatment Data
Date Received: 09/05/2018 Patient Sequence Number: 1
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