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

Model Number 37604

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Low impedance (2285); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Headache (1880); Unspecified Infection (1930); Dysphasia (2195); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Cognitive Changes (2551); Syncope/Fainting (4411); Insufficient Information (4580)

Event Date 12/04/2023

Event Type  malfunction  

Event Description

Schiff n.D., giacino j.T., butson c.R., choi e.Y., baker j.L., o'sullivan k.P., janson a.P., bergin m., bronte-stewart h.M., chua j., degeorge l., dikmen s., fogarty a., gerber l.M., krel m.Maldonado j., radovan m., shah s.A., su j., temkin n., tourdias thomas., victor j.D., waters a., kolahowsky-hayner s.A., fins j.J., machado a.G., rutt b.K., henderson j.M.Thalamic deep brain stimulation in traumatic brain injury: a phase 1, randomized feasibility study nature medicine 2023 doi: 10.1038/s41591-023-02638-4 abstract: converging evidence indicates that impairments in executive function and information-processing speed limit quality of life and social reentry after moderate-to-severe traumatic brain injury (mstbi).These defcits refect dysfunction of frontostriatal networks for which the central lateral (cl) nucleus of the thalamus is a critical node.The primary objective of this feasibility study was to test the safety and efcacy of deep brain stimulation within the cl and the associated medial dorsal tegmental (cl/dttm) tract.Six participants with mstbi, who were between 3 and 18 years post-injury, underwent surgery with electrode placement guided by imaging and subject-specifc biophysical modeling to predict activation of the cl/dttm tract.The primary efcacy measure was improvement in executive control indexed by processing speed on part b of the trail-making test.All six participants were safely implanted.Five participants completed the study and one was withdrawn for protocol non-compliance.Processing speed on part b of the trail-making test i mproved 15% to 52% from baseline, exceeding the 10% benchmark for improvement in all fve cases.Cl/dttm deep brain stimulation can be safely applied and may improve executive control in patients with mstbi who are in the chronic phase of recovery.  reported events: 1) patient 1 experienced an unplanned withdrawal of stimulation during the treatment phase, attributed in retrospect to passing through a magnetic theft detector system while shopping.Patient 1 experienced a decline in function over a 2-3 week period before notifying study investigators.Patient 1 experienced dysarthria with the activation of the lowest contact of electrodes in both hemispheres, with contact r2 of the right hemisphere eliciting the strongest effect.2) patient 4 had the top right sided electrode contact that appeared to be shorted in the ventricular cerebral spinal fluid.No further testing was done.Patient 4 also had sensorimotor side effects like impersistent lower extremity sensory side effects were present in the left and right sided contacts.Patient 4 also experienced rollover effects of increased arousal and akathisia required a tight restriction of both left and right hemispheres.Patient 4 also demonstrated a 10.6% decline in tmt-b performance.Patient 4 experienced insomnia and daytime sleepiness.

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name activa; product id 37601 (serial: unknown); product type: 0197-implantable neurostimulator; implant date ; explant date g2: citation: authors: schiff n.D., giacino j.T., butson c.R., choi e.Y., baker j.L., o'sullivan k.P., janson a.P., bergin m., bronte-stewart h.M., chua j., degeorge l., dikmen s., fogarty a., gerber l.M., krel m.Thalamic deep brain stimulation in traumatic brain injury: a phase 1, randomized feasibility study.Nature medicine 2023.Doi: 10.1038/s41591-023-02638-4 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.D.2.The device was used for an off label indication; see b5.Refer to manufacturer's report 2182207-2024-00046 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: 18443884
• MDR Text Key: 331891592
• Report Number: 2182207-2024-00052
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• 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: 12/13/2023
• 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
• Treatment: SEE H10...
• Patient Age: 36 YR
• Patient Sex: Male