MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Model Number S7 |
Device Problem
Imprecision (1307)
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Patient Problems
Tissue Damage (2104); Brain Injury (2219); Iatrogenic Source (2498)
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Event Date 02/09/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).On 02/26/2016, a medtronic representative, following-up at the site, reported patient exams looked reasonable.The big issue noted were flattened, mis-shapened, or compressed, fiducials.On 02/29/2016 patient archives analyzation completed.Findings are that patient exams were correctly done to medtronic imaging protocol.After adjusting the threshold the 3d model looked very good.No parts have been received by manufacturer for analysis.No further issues have been reported.(b)(4).
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Event Description
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A medtronic representative reported that, while in a cranial biopsy procedure, the surgeon alleged an inaccuracy and a failed biopsy.The patient was registered four times using touch-n-go registration, and pointmerge registration, however, the surgeon deemed being inaccurate each time.Each registration passed, however, navigation was 1-3 millimeters off.The surgeon opted to proceed with the biopsy with this knowledge.The patient was in the prone position and it was noted, had loose skin.Once registered, the surgeon attempted to take a biopsy sample but reported he only collected blood.Following the biopsy, the surgeon opened up the burr hole further and confirmed accurately the location of the tumor with the passive planar probe.The surgeon then replaced the navigus base and attempted to take another tissue sample using the biopsy needle.The second biopsy attempt, the surgeon reported no tissue was collected.The surgeon used navigation to identify the tumor and manually took a sample without use of biopsy needle.The tumor was approximately 15 millimeters off the surface of the skull.Delay in therapy was approximately 15 - 20 minutes.
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The software investigation concluded that the reported event was unrelated to a software issue.Per review of the software log images some of the fiducials were compressed on the patient scan.The software functioned as designed.The imaging protocol that accompanies the device contains the following warning regarding fiducial placement, "ensure positioning in the scanner does not shift any of the fiducials.".
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Search Alerts/Recalls
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