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); Hearing Impairment (1881); Memory Loss/Impairment (1958); Neuropathy (1983); Pain (1994); Anxiety (2328); Irritability (2421); Cognitive Changes (2551); Convulsion/Seizure (4406); Paresthesia (4421); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/07/2022

Event Type  malfunction  

Event Description

Graat, i., mocking, r.J.T., liebrand, l.C., munckhof, p., bot, m., schuurman, p.R., bergfeld, i.O., wingen, g., denys, d.Tractogr aphy-based versus anatomical landmark-based targeting in valic deep brain stimulation for refractory obsessive-compulsive disorder.Molecular psychiatry (2022).Https://doi.Org/10.1038/s41380-022-01760-y deep brain stimulation (dbs) of the ventral anterior limb of the internal capsule (valic) is effective for refractory obsessivecompulsive disorder (ocd).Retrospective evaluation showed that stimulation closer to the supero-lateral branch of the medial forebrain bundle (slmfb), within the valic, was associated with better response to dbs.The present study is the first to compare outcomes of dbs targeted at the valic using anatomical landmarks and dbs with connectomic tractography-based targeting of the slmfb.We included 20 ocd-patients with anatomical landmark-based dbs of the valic that were propensity score matched to 20 patients with tractography-based targeting of electrodes in the slmfb.After one year, we compared severity of ocd, anxiety and depression symptoms, response rates, time to response, number of parameter adjustments, average current, medication usage and stimulation-related adverse effects.There was no difference in y-bocs decrease between patients with anatomical landmark-based and tractography-based dbs.Nine (45%) patients with anatomical landmark-based dbs and 13 (65%) patients with tractographybased dbs were responders (bf10 = 1.24).The course of depression and anxiety symptoms, time to response, number of stimulation adjustments or medication usage did not differ between groups.Patients with tractography-based dbs experienced fewer stimulation-related adverse effects than patients with anatomical landmark-based dbs (38 vs 58 transient and 1 vs.17 lastingadverse effects; bf10 = 14.968).Ocd symptoms in patients with anatomical landmark-based dbs of the valic and tractographybased dbs of the slmfb decrease equally, but patients with tractography-based dbs experience less adverse effects.Reportable events: conventional dbs reported in total 58 transient adverse events and 17 lasting adverse events tractography-based dbs reported 38 transient adverse events and 1 lasting adverse event 11 patients experienced symptoms of hypomania one patient attempted suicide one patient experienced a manic episode when the dbs was turned on, which required psychiatric ward admission.2 mania 5 suicidal thoughts 14 hypomanic symptoms following stimulation adjustments (euphoria, hyperactivity, insomnia, restlessness, impulsivity) 1 manic episode following stimulation adjustments 9 irritability 17 sleeping problems 8 fatigue 16 restlessness 2 panic attacks 6 impulsivity 2 increased libido 1 sensitivity to sound 2 psychotic symptoms 3 tics 1 depressive symptoms 1 aggression 1 grinding teeth 2 restless legs syndrome 1 hearing problem 7 memory problem 2 concentration problem 2 muscular complaints 6 headache 1 epileptic insult 1 palpitations 1 auto mutilation 1 pain in stomach 1 neuropathy 2 decreased apatite 10 paresthesia see attached literature article.

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patient in the study.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.G4) 510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.If information is provided in the future, a supplemental report will be issued.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15675173
• MDR Text Key: 306886951
• Report Number: 3004785967-2022-00704
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K200074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 10/13/2022
• Initial Date FDA Received: 10/26/2022
• 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 Age: 40 YR
• Patient Sex: Female