MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) MEDTRONIC NAVIGATION

Model Number UNK_OARM_SYS

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

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal article.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date the article was accepted as the event dates were not provided in the published literature.Article citation is included.No procode provided as the system is unknown.System product number and serial number not provided in journal article.Udi not available for this system.No 510k provided as system is unknown.No evaluation was performed as this event was reported in literature.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: frizon l.A., shao j., maldonado-naranjo a.L., lobel d.A., nagel s.J., fernandez h.H., machado a.G.2018.The safety and efficacy of using the o-arm intraoperative imaging system for deep brain stimulation lead implantation.Neuromodulation 2018; 21: 588¿592.Doi: 10.1111/ner.12744.Summary: introduction: accurate electrode implantation is a major goal of deep brain stimulation (dbs) surgery.Intraoperative physiology with microelectrode recording (mer) is routinely used to refine stereotactic accuracy during awake electrode implantation.Recently, portable imaging systems such as the o-arm have become widely available and can be used in isolation or in association with mer to guide dbs lead placement.The aim of this study was to evaluate how the routine use of the o-arm affected dbs surgery safety, efficiency, and outcomes.Methods: two cohorts of patients with parkinson¿s disease who underwent mer-guided awake subthalamic dbs lead implantation with and without o-arm were compared.We examined the total number of microelectrode and macroeletrode passes during each surgery, procedure duration, surgical complications, lead revisions, and motor outcomes.Results: a total of 50 procedures in 41 unique patients were analyzed, of which 26 were performed without o-arm and 24 performed without the o-arm.The mean number of microelectrode passes was 2.46 (sd = 0.99) in the group without o-arm utilization, compared to 1.29 (sd = 0.75) in the group with o-arm usage (p <(><<)> 0.001).A significant reduction was also found in procedure duration (p = 0.016).No differences were found in motor outcomes between groups.Conclusion: the use of the o-arm during dbs lead implantation was associated with significantly fewer brain cannulations for microel ectrode recording as well as reduced surgical time.Reported events: one patient presented with a postoperative infection and was treated with lead removal and antibiotic therapy.The lead was re-implanted four months later.One patient presented with a postoperative asymptomatic subdural hematoma.The patient was monitored and no further surgery was necessary.

• Brand Name: MEDTRONIC NAVIGATION
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9147838
• MDR Text Key: 163120097
• Report Number: 3004785967-2019-01724
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK_OARM_SYS
• Device Catalogue Number: UNK_OARM_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2019
• 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