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

Model Number UNK_OARM_SYS

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

Patient Problem Cognitive Changes (2551)

Event Date 03/14/2022

Event Type  Injury  

Event Description

Fenoy, a.J., schulz, p.E., sanches, m., selvaraj, s., burrows, c.L., asir, b., conner, c.R., quevedo, j., <(>&<)>amp; soares, j.C.(2022).Deep brain stimulation of the ¿medial forebrain bundle¿: sustained efficacy of antidepressant effect over years.Molecular psychiatry.Https://doi.Org/10.1038/s41380-022-01504-y summary: deep brain stimulation (dbs) to the superolateral branch of the medial forebrain bundle (mfb) has emerged as a quite efficacious therapy for treatment resistant depression (trd), leading to rapid antidepressant effects.In this study, we complete our assessment of our first 10 enrolled patients throughout one year post-implantation, showing sustained antidepressant effect up to 5 years.The primary outcome measure was a 50% reduction in montgomery-åsberg depression rating scale (madrs) score, which was interpreted as a response.Deterministic fiber tracking was used to individually map the target area.An insertional effect was seen during the 4-week sham stimulation phase (29% mean madrs reduction, p = 0.02).However, after 2 weeks of initiating stimulation, five patients met response criteria (47% mean madrs reduction, p <(><<)> 0.001).One patient withdrew from study participation at 6 weeks.Twelve weeks after initiating stimulation, six of nine remaining patients had a >50% decrease in madrs scores relative to baseline (52% mean madrs reduction, p = 0.001); these same six patients continued to meet response criteria at 52 weeks (63% overall mean madrs reduction, p <(> <<)> 0.001).Four of five patients who achieved the 5-year time point analysis continued to be responders (81% mean madrs reduct ion, p <(><<)> 0.001).Evaluation of modulated fiber tracts reveals significant common prefrontal/ orbitofrontal connectivity to the target region in all responders.Key points learned from this study that we can incorporate in future protocols to better elucidate the effect of this therapy are a longer blinded sham stimulation phase and use of scheduled discontinuation concomitant with functional imaging.Reported events: ten patients with a histology of major depressive disorder underwent a dbs procedure.Post operatively, one patient ,over time, became increasingly consumed by their body dysmorphia.The patient felt it was due to the dbs, so just after two years they requested that the system be removed.Please see attached article.

Manufacturer Narrative

Patient information was not included in the journal entry.This value reflects the mean age of the patients who underwent the dbs procedure as specific patients could not be identified.This value reflects the majority gender of the patients who underwent the dbs procedure as specific patients could not be identified.The article did not provide the date of the procedure.The event date provided is the published online date.The article citation is included.The system product number and serial number were not provided in the journal article.Udi not available for this system.No 510k provided as system is unknown.No evaluation was performed as the event was reported as a literature article.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

• Brand Name: O-ARM IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14044316
• MDR Text Key: 288810037
• Report Number: 3004785967-2022-00245
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2022

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_OARM_SYS
• Device Catalogue Number: UNK_OARM_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/07/2022
• 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): Other
• Patient Age: 50 YR
• Patient Sex: Female