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

Model Number POLESTAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Iatrogenic Source (2498); Cognitive Changes (2551)

Event Date 08/24/2011

Event Type  Injury  

Manufacturer Narrative

Patient weight was not provided in the article, but was requested from the surgeon via email.Senft c, bink a, franz k, vatter h, gasser t, seifert v.Intraoperative mri guidance and extent of resection in glioma surgery: a randomised, controlled trial.Lancet oncology.2011; 12: 997¿1003.Doi:10.1016/s1470- 2045(11)70196-6.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.Article concludes the following: intraoperative imaging led to continued resection of contrast enhancing tissue in a third of patients in the intraoperative mri group.Had intraoperative imaging not been used, the resection rates between treatment groups would no longer differ significantly.The beneficial effect of intraoperative mri is probably due to the ability to reassess neuronavigation during surgery.Neuronavigation is usually based upon preoperative imaging, and anatomy is altered during surgery due to resection of tissue and loss of cerebrospinal fluid.These alterations, so-called brain-shift, render conventional neuronavigation somewhat inaccurate after dura opening and during tumour resection.Therefore, tumour remnants can be overlooked.Intraoperative imaging can be used to depict these remnants, and restore the accuracy of neuronavigation.In this study, extent of resection in the intraoperative mri group was better than it was in the control group even after exclusion of surgeries done without the use of a neuronavigation system.Importantly, our data show that this enhanced resection was not achieved at the cost of increased surgical morbidity.The overall complication rate in this study was within previously reported limits, and complications did not occur in patients in whom intraoperative mri led to continued resection of tumour tissue.Use of intraoperative mri thus improves the neurosurgeon¿s goal of extensive but safe tumour resection.

Event Description

Per attached article, listed in table 3, patient 21 of the intraoperative mri group, who underwent resection for right frontal glioblastoma had 0% residual tumor, but had a postoperative psychotic episode.Four additional mdrs (1723170-2016-01223, 1723170-2016-01224, 1723170-2016-01226, 1723170-2016-01227) will be submitted for the other 4 patients specifically mentioned in table 3.

• Brand Name: POLESTAR INTEGRATION 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: catherine eaton ; 826 coal creek circle; louisville, CO 80027 ; 7208902092
• MDR Report Key: 5746689
• MDR Text Key: 48095383
• Report Number: 1723170-2016-01225
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: POLESTAR
• Device Catalogue Number: 9732703
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2005
• 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): Required Intervention
• Patient Age: 50 YR