• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NAVIGATION, INC. (LOUISVILLE) POLESTAR INTEGRATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number POLESTAR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Brain Injury (2219); Iatrogenic Source (2498); No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2011
Event Type  Injury  
Manufacturer Narrative
The iomri-guided stereotactic biopsies were done on 39 patients. Their age ranged from 5 years to 86 years, with a mean of 49 years. There were 25 male and 14 female patients. Schulder, m. , & spiro, d. (2011) intraoperative mri for stereotactic biopsy. Per article: intraoperative imaging offers several advantages in this regard brain shifts that may occur with dural opening can be accounted for; if a non-lesional frozen section is obtained, repeat imaging and targeting can be done during the same surgery; the surgeon can ensure that the biopsy is taken from the area most likely to yield a diagnosis; with serial imaging during biopsy, unnecessary penetrations with the cannula can be avoided; hemorrhage can be ruled out at the end of the procedure. In conclusion: intraoperative imaging enables the surgeon to compensate for brain shift, to re-image and retarget as necessary, and to rule out intracranial bleeding.
 
Event Description
Per article, iomri-guided biopsy was done in 39 patients, of whom 28 had neoplasms and 11 had non-neoplastic conditions. Additional or time related to the use of iomri (including positioning of the patient and magnet, and imaging acquisition) averaged 1. 1 h. In 53% of the surgeries the biopsy cannula was repositioned based on intraoperative imaging. A histologic diagnosis was obtained in all but one patient, with iomri confirming proper cannula placement in all cases. There were no significant hemorrhages on clinical or imaging grounds nor any other complications. Biopsies were done using the polestar n-20 iomri (medtronic navigation, (b)(4), usa) under general anesthesia. Images were acquired after patient positioning and after insertion of an mri-compatible biopsy cannula. A navigus guide (medtronic navigation) was used to align and direct the cannula. Retargeting was done as necessary, to improve placement within the target and to avoid critical structures, using the system¿s integrated infrared navigation tool. Cannula placement was tracked using serial images. Diagnoses included high grade glioma in 15 patients, low grade glioma in 11, lymphoma in 1, and embryonal cell carcinoma in 1; and 10 patients had non-neoplastic lesions, including 3 bacterial abscesses. In one patient, although increased cellularity was seen, no definitive diagnosis was made. Intraoperative images showed the biopsy cannula to be within the enhancing component of the lesion (this patient remains neurologically intact, with stable mri findings, 1 year later). Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's polestar integration navigation system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePOLESTAR INTEGRATION 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
catherine eaton
826 coal creek circle
louisville, CO 80027
7208902092
MDR Report Key6559013
MDR Text Key74888039
Report Number1723170-2017-02033
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 Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 05/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPOLESTAR
Device Catalogue Number9732702
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2006
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: 05/10/2017 Patient Sequence Number: 1
Treatment
(B)(4)
-
-