MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC POLESTAR N20 SURGICAL MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number UNK_NAV_SYS

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Memory Loss/Impairment (1958); Paresis (1998); Meningitis (2389)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

Patient age is the average value of the 21 patients in the study.Patient gender is the average value of the 21 patients in the study.Patient weight not available from the site.Device lot number, or serial number, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: pawel tabakow, artur weiser, kryzsztof chmielak, przemyslaw blauclak, joanna bladowska, marcin czyz.Navigated neuroendoscopy combined with intraoperative magnetic resonance cysternography for treatment of arachnoid cysts.Neurosurgical review doi.Org/10.1007/s10143-019-01136-x abstract endoscopic cystocysternostomy or cystoventriculostomy is the treatment of choice in patients with symptomatic intracranial arachnoid cysts.There are no objective diagnostic tests for reliable intraoperative evaluation of the effectiveness of performed stomies.The aim of this prospective open-label study is to demonstrate for the first time the usefulness of intraoperative cysternography performed with the low-field 0.15-t magnetic resonance imager polestar n20 during endoscopic cysternostomies.The study was performed in patients operated for middle fossa arachnoid cysts (n = 10), suprasellar cysts (n = 4), paraventricular or intraventricular cysts (n = 6), and a pineal cyst (n = 1).The operations were performed with use of a navigated neuroendoscope.Intraoperative magnetic resonance (imr) cysternography was performed before and after the cystostomy.In each case, imr cysternography was safe and could show clearly the cyst morphology and the effectiveness of performed endoscopic cystostomies.In six cases, imr cysternography had a significant influence of the surgical decision (p = 0.027).The rate of inconsistency between the intraoperative observations and imr imaging based findings was 29%.A good contrast flow through the fenestrated cyst walls correlated with a good long-term clinical outcome (p = 0.54, p < 0.05) and good long-termradiological outcome (p = 0.72, p < 0.05).Intraoperative low-fieldmrcysternography is a safe and reliable method for assessment of the efficacy of performed endoscopic cystostomies and has significant influence on the surgical decision.It may be reliably used for prediction of the long-term clinical and radiological outcome.Reported events: 51 yr, f cerebrospinal fluid (csf) leak through the wound.65 yr, f cerebrospinal fluid (csf) leak through the wound that resulted in subclinical meningitis (asymptomatic csf pleocytosis) that was successfully treated pharmacologically.22 yr, m abducens nerve paresis that lasted several hours.0.25 yr (3 months) m case of pseudomeningocele where the patient had an intraventricular cyst.13 yr, m transient paresis of the oculomotor nerve.19 yr, m transient memory deficit.

• Brand Name: POLESTAR N20 SURGICAL MRI SYSTEM
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8945080
• MDR Text Key: 157777808
• Report Number: 1723170-2019-04678
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K092308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 27 YR