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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TREON
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hemorrhage, Subdural (1894); Iatrogenic Source (2498)
Event Date 03/11/2017
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 52 and the consisted of 18 male and 48 female patients in the study. Therefore (b)(6) years old and female 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: shamik chakraborty, salvatore zavarella, sussan salas and michael schulder. Intraoperative mri for resection of intracranial meningiomas. (2017). Journal of experimental therapeutics and oncology, vol. 12, pp. 157-162 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 this product is no longer manufactured. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. Multiple attempts have been made to obtain additional information. 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. Per the journal article, author reported that no evidence of infarct seen on the intraoperative scan, therefore they believe it occurred after surgery. Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's imaging system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event. Not returned by customer.
 
Event Description
The attached journal article was forwarded by a medtronic representative. Use of imaging system was reported. This is medical device report (mdr) one of two. For the second mdr, see 1723170-2018-01092. Over a ten-year period, 70 operations were performed on 66 patients with intracranial meningiomas using the medtronic imaging system. The mean age was 52 years with 18 male and 48 female. There was one patient mortality in a patient who had a right sphenoid wing meningioma resected and suffered a severe stroke one day postoperatively. There was no evidence of infarct seen on the intraoperative scan, so we believe it occurred after surgery. In all other patients, postoperative diagnostic mri was concordant with findings on intraoperative images. Up to 15. 7% of patients had surgery positively affected by intraoperative imaging either improving the resection or avoiding unnecessary additional dissection which could potentially harm critical neurologic structures.
 
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Brand NameSTEALTHSTATION TREON TREATMENT GUIDANCE 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
826 coal creek circle
louisville, CO 80027
7208903200
MDR Report Key7329155
MDR Text Key102063369
Report Number1723170-2018-01088
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTREON
Device Catalogue Number9680111
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 Received02/14/2018
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: 03/09/2018 Patient Sequence Number: 1
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