MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number BI70002000

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

Patient Problems Headache (1880); Intracranial Hemorrhage (1891)

Event Date 01/14/2021

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: patient age is the mean value of patients in the xt group.Sex) patient gender is the majority value of patients in the xt group.Weight: patient weight not available from the site.Event date is the online publishing date of the literature article.Device lot number, or serial number, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacture date is dependent on the device lot/serial number, therefore is unavailable.Mdr 1723170-2021-02380 documents the medtronic navigation system used in the literature article.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: carlos e.Restrepo, david b.Clarke, p.Daniel mcneely, matthew d.Cooper, murray hong, ron hill, lutz m.Weise.Validation of 3d fluoroscopy for image-guidance registration in depth electrode implantation for medically refractory epilepsy.Acta neurochirurgica (2021) 163:1347-1354.Https://doi.Org/10.1007/s00701-021-04706-5.Abstract: background: frame registration is a critical step to ensure accurate electrode placement in stereotactic procedures such as stereo electroencephalography (seeg) and is routinely done by merging a computed tomography (ct) scan with the preoperative magnetic resonance (mr) examination.Three-dimensional fluoroscopy (xt) has emerged as a method for intraoperative electrode verification following electrode implantation and more recently has been proposed as a registration method with several advantages.Methods: we compared the accuracy of seeg electrode placement by frame registration with ct and xt imaging by analyzing the euclidean distance between planned and post-implantation trajectories of the seeg electrodes to calculate the error in both the entry (ep) and target (tp) points.Other variables included radiation dose, efficiency, and complications.Results: twenty-seven patients (13 ct and 14 xt) underwent placement of seeg electrodes (319 in total).The mean ep and tp errors for the ct group were 2.3 mm and 3.3 mm, respectively, and 1.9 mm and 2.9 mm for the xt group, with no statistical difference (p = 0.75 and p = 0.246).The time to first electrode placement was similar (xt, 82 ¿ 10 min; ct, 84 ¿ 22 min; p = 0.858) and the average radiation exposure with xt (234 ¿ 55 mgy*cm) was significantly lower than ct (1245 ¿ 123 mgy*cm) (p < 0.0001).Four complications were documented with equal incidence in both groups.Conclusions: the use of xt as a method for registration resulted in similar implantation accuracy compared with ct.Advantages of xt are the substantial reduction in radiation dose and the elimination of the need to transfer the patient out of the room which may have an impact on patient safety and or efficiency.Reported events: two patients experienced intracranial hemorrhages in post-operative computed tomography (ct) scans.A.One hemorrhage was noted to be symptomatic with a transient mild headache and no neurological deficit.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12537330
• MDR Text Key: 273532084
• Report Number: 3004785967-2021-01150
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K200074
• 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: 09/27/2021

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: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 09/27/2021
• 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: 40 YR