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

Model Number NEU_INS_STIMULATOR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Suicidal Ideation (4429)

Event Date 12/28/2023

Event Type  Injury  

Manufacturer Narrative

A: select patient information cannot be included in regulatory report due to regional privacy regulations.B.3.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.D10.Section d information references the main component of the system.Other relevant device(s) are: product id: 3387, serial/lot #: unknown, https://www.Brainstimjrnl.Com/article/s1935-861x(23)01979-4/fulltext.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

Persad ar, coote nr, waterhouse k, et al.Medial forebrain bundle stimulation after failed subcallosal cingulate deep brain stimulation for treatment-resistant depression: efficacy of a dual deep brain stimulation system for depression.Brain stimul.2023;17(1):68-70.Doi: 10.1016/j.Brs.2023.12.014.Reported events: two patients had subcallosal cingulate cortex (scc) dbs performed without sustained symptom relief who then had medial forebrain bundle (mfb) dbs and had improved symptom relief with both systems activated.In both cases, the effects of having both systems exceed the effect of either system individually.  1.One patient had 15 year history of depression.The patient received scc unit 5 years prior due to recurrent suicidal ideation.They had electroconvulsive therapy with minimal results.Following scc dbs, they initially felt mild improvement but this was transient.Three years following scc dbs, the patient was admitted to hospital with a suicide attempt.Their psychiatrist recommended mfb dbs due to inadequate response to scc dbs. the patient reported subjective improvement at 1-week follow-up.Their scc dbs started off, but was turned on at 5-month follow-up.They had further clinical improvement with both systems on.The patient's family immediately noticed change after mfb dbs battery stopped working at 18 months follow-up, but took longer to notice differences after the scc dbs battery failed.The patient had no suicide or self-harm attempts since mfb dbs.They were able to stop aripiprazole on dual stimulation.The following device specifics was provided: lead model 3387.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• 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: 18731182
• MDR Text Key: 335691375
• Report Number: 2182207-2024-00780
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• 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
• Treatment: "SEE H11...."
• Patient Outcome(s): Hospitalization; Life Threatening