MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number 37612

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 12/02/2023

Event Type  Injury  

Manufacturer Narrative

G2: citation: authors: liker m.A., sanger t.D., maclean j.A., nataraj j., arguelles e., krieger m., robison a., olaya j.Stereotactic awake basal ganglia electrophysiological recording and stimulation (sabers): a novel staged procedure for personalized targeting of deep brain stimulation in pediatric movement and neurop.Child neurology 2023.Doi: 10.1177/08830738231224057 without return of the product no definitive conclusion can be made regarding the clinical observations.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.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Liker m.A., sanger t.D., maclean j.A., nataraj j., arguelles e., krieger m., robison a., olaya j.Stereotactic awake basal ganglia electrophysiological recording and stimulation (sabers): a novel staged procedure for personalized targeting of deep brain stimulation in pediatric movement and neuropsychiatric disorders child neurology 2023 doi: 10.1177/08830738231224057 abstract selection of targets for deep brain stimulation (dbs) has been based on clinical experience, but inconsistent and unpredictable outcomes have limited its use in patients with heterogeneous or rare disorders.In this large case series, a novel staged procedure for neurophysiological assessment from 8 to 12 temporary depth electrodes is used to select targets for neuromodulation that are tailored to each patient¿s functional needs.Thirty children and young adults underwent deep brain stimulation target evaluation with the new procedure: stereotactic awake basal ganglia electrophysiological recording and stimulation (sabers).Testing is performed in an inpatient neuromodulation monitoring unit over 5-7 days, and results guide the decision to proceed and the choice of targets for permanent deep brain stimulation implantation.Results were evaluated 3-6 months postoperatively with the burke-fahn-marsden dystonia rating scale and the barry-albright dystonia scale.Stereotactic awake basal ganglia electrophysiological recording and sti mulation testing allowed modulation to be tailored to specific neurologic deficits in a heterogeneous population, including subjects with primary dystonia, secondary dystonia, and tourette syndrome.All but one subject were implanted with 4 permanent deep brain stimulation leads.Results showed significant improvement on both scales at postoperative follow-up.No significant adverse events occurred.Use of the stereotactic awake basal ganglia electrophysiological recording and stimulation protocol with evaluation in the neuromodulation monitoring unit is feasible and results in significant patient benefit compared with previously published results in these populations.This new technique supports a significant expansion of functional neurosurgery to predict effective stimulation targets in a wide range of disorders of brain function, including those for which the optimal target is not yet known.Reported events: 1) 2 patients had wound or device infection due to mechanical trauma to the wound, usually due to wheelchair straps, involuntary head movement, or direct trauma due to involuntary movement.See attached literature article for reference.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 18977808
• MDR Text Key: 338586921
• Report Number: 2182207-2024-02116
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• 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 Age: 12 YR
• Patient Sex: Male