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

Model Number	37601
Medical Device Problem Codes	Low impedance (2285); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Unspecified Infection (1930); Sleep Dysfunction (2517); Ambulation or Postural Difficulties (2544); Cognitive Changes (2551); Syncope/Fainting (4411); Paresthesia (4421); Insufficient Information (4580)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name ; product id neu_unknown_ext (serial: unkown); product type: 0191-extension; brand name activa; product id 3387 (serial: unknown); product type: 0200-lead; brand name activa; product id 37601 (serial: unknown); product type: 0197-implantable neurostimulator; 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.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 or Problem 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: patient 2 had an infection of the dbs device that resulted in an explant of the system and antibiotics for 6 days while being hospitalized.The issue has been resolved.Patient 3 had syncope while standing to urinate that required hospitalization.Patient 3 also experienced headaches and gait disturb ances.The adverse events have been resolved.Patient 3 also experienced an abnormality of jaw sensation with the activation of the lowest left sided contact in monopolar mode.Patient 3 demonstrated a 34.1% decline in tmt-b performance.See attached literature articles.
Event or Problem Description
Reported events for patient 3: patient 3 had syncope while standing to urinate that required hospitalization.The event was possibly related to the study device.No actions were taken.The issue resolved.The patient experienced headaches possibly related to the study device.Medication was given.The issue resolved.The patient experienced gait disturbances possibly related to the study device.No action was taken.The issue resolved.The patient experienced an abnormality of jaw sensation with the activation of the lowest left sided contact in monopolar mode.A figure showed: - l1 - 150hz, 90us, 0-4.5v, sensory: 3.2v - tingling in jaw and throat.The patient randomized to the off (dbs amplitudes set to zero) condition and demonstrated a 34.1% decline in tmt-bscore (condition off) consistent with a withdrawal effect.Additional information was received from the corresponding author reporting that none of the adverse events could be attributed to the device.
Additional Manufacturer Narrative
Additional review indicates the infection event for patient 2 was previously reported in manufacturer¿s report #3007566237-2019-02049.Any additional information regarding the infection will be submitted as a supplemental submission to that report.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ACTIVA
• Common Device Name: 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: 18443727
• Report Number: 2182207-2024-00046
• Device Sequence Number: 15415662
• Product Code: MHY
• UDI-Device Identifier: 00763000310332
• UDI-Public: 00763000310332
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 06/12/2024
• Date Device Manufactured: 02/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10...
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male