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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 Imprecision (1307)
Patient Problems Intracranial Hemorrhage (1891); Injury (2348); Iatrogenic Source (2498)
Event Date 01/05/2018
Event Type  Injury  
Manufacturer Narrative
Patient age and sex were not provided by journal article author. Based on the article information, there were 26 males and 21 males average age of 41. 8 years old. Therefore, male and 42 years old were used. Patient weights were not available by the journal article authors. Event date is approximated. Date provided is when the journal article was published. Citation: jonathan c. Lau, suzanne e. Kosteniuk, david r. Macdonald, and joseph f. Megyesi. Image-guided ommaya reservoir insertion for intraventricular chemotherapy: a retrospective series. (2018). Acta neurochirurgica. Https://doi. Org/10. 1007/s00701-017-3454-z 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. 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, the infection occurred beyond the early post-operative period (more than 1 months post-op) and after intraventricular treatment had been initiated. The system was removed 3 months post-op due to isolated infection on culture. Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's image guidance system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event. Author indicated there were no catheter malfunction, early infection or death.
 
Event Description
The attached journal article was forwarded by a medtronic representative. Use of the navigation system was reported. This is medical device report (mdr) three of three. See 1723170-2018-00533 for the first mdr and 1723170-2018-00534 for the second mdr. This is a retrospective study for the cases occurred from 2000 to 2014. Fifty-five consecutive patients underwent ori by the senior author over the study period (43. 5 ± 16. 6 years; 40. 0% female). Forty-seven of those patients underwent surgery with navigation system. Average age for the patients was 41. 8 years old, 26 male and 21 female per table 1. One (1) case of malposition, 2 cases of infection and 2 cases of hemorrhage were reported as complications on table 2 for the patient who underwent surgery with navigation. Author identified two infections requiring removal of the ommaya reservoir identified several months after the initial surgery, both of which were in the navigation group. In conclusion, use of image guidance resulted in fewer operative complications including fewer catheter malpositions and more single-pass procedures. The results support routine use of intraoperative image guidance for proximal catheter insertion in elective ommaya reservoir placement for intraventricular chemotherapy.
 
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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
826 coal creek circle
louisville, CO 80027
7208903200
MDR Report Key7300006
MDR Text Key101059821
Report Number1723170-2018-00535
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCA
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 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received02/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2012
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: 02/27/2018 Patient Sequence Number: 1
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