MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37604

Device Problem Malposition of Device (2616)

Patient Problems Depression (2361); Irritability (2421); Cognitive Changes (2551)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

Fins, j., wright, m., henderson, j., schiff, n.(2022).Subject and family perspectives from the central thalamic deep brain stimulation for traumatic brain injury study: part i.Cambridge quarterly of healthcare ethics, 31(4), 419-443.Doi: (b)(4) abstract this is the first article in a two-part series describing subject and family perspectives from the central thalamic deep brain stimulation for the treatment of traumatic brain injury using the medtronic pc+s first-in-human invasive neurological device trial to achieve cognitive restoration in moderate to severe traumatic brain injury, with subjects who were deemed capable of providing voluntary informed consent.In this article, we report on interviews conducted prior to surgery wherein we asked participants about their experiences recovering from brain injury and their perspectives on study enrollment and participation.We asked how risks and benefits were weighed, what their expectations and fears were, and how decisions were reached about trial participation.We found that informed consent and enrollment decisions are fraught.Subjects and families were often split, with subjects more focused on putative ben efits and families concerned about incremental risk.Both subjects and families viewed brain injury as disruptive to personal identity and relationships.As decisions were made about study enrollment, families struggled with recognizing the re-emergent agency of subjects and ceding decision-making authority to subjects who had previously been dependent upon them for protection and guidance.Subjects and family members reported a hope for the relief of cognitive disabilities, improved quality of life, normalization of interpersonal interactions, and a return to work or school as reasons for study participation, along with altruism and a desire to advance science.Despite these aspirations, both subjects and families appreciated the risks of the intervention and did not suffer from a therapeutic misconception.A second essay to be published in the next issue of cambridge quarterly of healthcare ethics¿clinical neuroethics will describe interviews conducted after surgery, the effects of cognitive restoration for subjects, families, and challenges presented to the social structures they will call upon to support them through recovery.This subsequent article will be available online prior to its formal publication in october 2023.2023-apr-06, e2, e3, e4 (lit, hcp): additional information was received reporting that the postoperative wound infection resolved.Fins, j., wright, m., shulman, k., henderson, j., schiff, n.(2023).Subject and family perspectives from the central thalamic deep brain stimulation trial for traumatic brain injury: part ii.Cambridge quarterly of healthcare ethics 2023: doi: (b)(4) abstract this is the second paper in a two-part series describing subject and family perspectives from the century s (central thalamic deep brain stimulation for the treatment of traumatic brain injury-safety) first-in-human invasive neurological device trial to achieve cognitive restoration in moderate to severe traumatic brain injury (mstbi).To participate, subjects were independently assessed to formally establish decision-making capacity to provide voluntary informed consent.Here, we report on post-operative interviews conducted after a successful trial of thalamic stimulation.All five mstbi subjects met a pre-selected primary endpoint of at least a 10% improvement in completion time on trail-making-test part b, a marker of executive function.We describe narrative responses of subjects and family members, refracted against that success.Interviews following surgery and the stimulation trial revealed the challenge of adaptation to improvements in cognitive function and emotional regulation as well as altered (and restored) relationships and family dynamics.These improvements exposed barriers to social reintegration made relevant by recoveries once thought inconceivable.The study¿s success sparked concerns about post-trial access to implanted devices, financing of device maintenance, battery replacement, and on-going care.Most subjects and families identified the need for supportive counseling to adapt to the new trajectory of their lives.Reported events: 1)patient 336 experienced minimal improvement in losing/forgetting things.The patient also had issues with getting emotional, increased level of depression, irritability, impulsivity, and a lack of motivation.The patient can also feel their implantable neurostimulator (ins) sticking out of their chest a bit.See attached literature articles.

Manufacturer Narrative

· a.2.This value is the average age of the patients reported in the article as specific patients could not be identified.· a.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.· b.3.Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.· b.5.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Refer to manufacturer's report 2182207-2023-00033 for details pertaining to the reportable related event.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18221528
• MDR Text Key: 330554887
• Report Number: 2182207-2023-02601
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37604
• Device Catalogue Number: 37604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Male