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

Model Number 37601

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/27/2022

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical products: product id: 3389, lot#: unknown, product type: lead.The main component of the system.Other relevant device(s) are: product id: 3389, serial/lot #: unknown.This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event.Please note that this date is based off the date that the article was accepted for publication as the event dates were not provided in the published literature.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.

Event Description

Isidoor o.Bergfeld, pieter ooms, anja lok, lara de rue, pieter vissers, dirk de knijff, ferdinand horst, guus beute, pepijn van den munckhof, p.Richard schuurman, damiaan denys.Efficacy and quality of life after 6e9 years of deep brain stimulation for depression.Elsevier.Doi: 10.1016/j.Brs.2022.06.010.Background: given the invasiveness of deep brain stimulation (dbs), the effect should prove to be stable over the long-term and translate into an improvement of quality of life (qol).Objective: to study the effectiveness and qol up to nine years after the dbs surgery.Methods: we treated 25 adult patients with major depression with dbs of the ventral anterior limb of the internal capsule (valic).We followed them up naturalistically for 6e9 years after surgery (mean: 7.7 [sd:1.5] years), including a randomized crossover phase after the first year comparing sham with active dbs.Symptom severity was quantified using the hamilton depression scale with response defined as a 50% decrease of the score compared to baseline.Quality of life was measured using the whoqol-bref, assessing 5 domains (general, physical, psychological, social, environmental).Results: intention-to-treat response rates remained mostly stable from year 3 to last follow-up (year 3, 5 and 6: 40%; year 4: 36%; last observation: 44%).General, physical, psychological (all p < 0.001) and the environmental (p ¼ 0.02) domain scores increased during dbs optimization and remained stable over the long term.No statistically significant changes were detected on the social domain.Patients scored significantly higher during active than sham dbs on the psychological, social and environmental domains, and trended towards a higher score on the general and physical domains.Conclusion: this study shows continued efficacy of valic dbs in depression, which translates into an improvement of qol providing further support for dbs as a durable treatment for trd.Reported events: 1.It was reported that patients that underwent bilateral deep brain stimulation in the ventral anterior limb of the internal capsule (valic) had a combined 5 suicide attempts recorded in the first two years after getting dbs.2.It was reported that one patient that underwent bilateral deep brain stimulation in the ventral anterior limb of the internal capsule (valic) had an extension cable break, leading to unilateral malfunctioning of an electrode and a subsequent increase in depressive symptoms.The extension cable was replaced and the patient had a complete recovery.

• 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: 15237484
• MDR Text Key: 298024288
• Report Number: 2182207-2022-01579
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female