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

Model Number 37601

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

Patient Problems Intracranial Hemorrhage (1891); Paresis (1998); Dysphasia (2195)

Event Date 01/23/2017

Event Type  Injury  

Manufacturer Narrative

Note, this event was previously reported under 3007566237-2013-02552 until additional information received in a subsequent publication provided patient identifying information.Please note that this date is based off of the date that the article was accepted for publication as the event dates were not p rovided in the published literature.Other applicable components are: product id: 3389, lot# unknown, product type: lead.

Event Description

Bewernick, bh., kayser, s., gippert, sm., switala, c., coenen, va., schlaepfer, te.Deep brain stimulation to the medial forebrain bundle for depression-long-term outcomes and a novel data analysis strategy.Brain stimul.2017;2017 feb 9.Doi: 10.1016/j.Brs.2017.01.581.Summary: background: deep brain stimulation (dbs) of the supero-lateral branch of the medial forebrain bundle (slmfb) in treatment-resistant depression (trd) is associated with acute antidepressant effects.Objective: long-term clinical effects including changes in quality of life, side effects and cognition as well as long-term data covering four years are assessed.Methods: eight trd patients were treated with dbs bilateral to the slmfb.Primary outcome measure was a 50% reduction in montgomery-åsberg depression rating scale (madrs) (response) and remission (madrs <(><<)>10) at 12 months compared to baseline.Secondary measures were anxiety, general functioning, quality of life, safety and cognition assessed for 4 years.Data is reported as conventional endpoint-analysis and as area under the curve (auc) timeline analysis.Results: six of eight patients (75%) were responders at 12 months, four patients reached remission.Long-term results revealed a stable effect up to four years.Antidepressant efficacy was also reflected in the global assessment of functioning.Main side effect was strabismus at higher stimulation currents.No change in cognition was identified.Auc analysis revealed a significant reduction in depression for 7/8 patients in most months.Conclusions: long-term results of slmfb-dbs suggest acute and sustained antidepressant effect; timeline analysis may be an alternative method reflecting patient's overall gain throughout the study.Being able to induce a rapid and robust antidepressant effect even in a small, sample of trd patients without significant psychiatric comorbidity, render the slmfb an attractive target for future studies.Schlaepfer, t.E., bewernick, b.H., kayser, s., madler, b., coenen, v.A.Rapid effects of deep brain stimulation for treatment-resistant major depression.Biological psychiatry.2013;73(12):1204-1212.Doi: 10.1016/j.Biopsych.2013.01.034.Summary: treatment-resistant major depressive disorder is a prevalent and debilitating condition.Deep brain stimulation to different targets has been proposed as a putative treatment.In this pilot study, we assessed safety and efficacy of deep brain stimulation to the supero-lateral branch of the medial forebrain bundle in seven patients with highly refractory depression.Primary outcome criterion was severity of treatment-resistant major depressive disorder as assessed with the montgomery-°asberg depression rating scale.General psychopathologic parameters, social functioning, and tolerance were assessed with standardized scales, the global assessment of functioning scale, quality of life (short-form health survey questionnaire), and neuropsychological tests.All patients showed strikingly similar intraoperative effects of increased appetitive motivation.Six patients attained the response criterion; response was rapid¿mean montgomery-°asberg depression rating scale of the whole sample was reduced by >50% at day 7 after onset of stimulation.At last observation (12¿33 weeks), six patients were responders; among them, four were classified as remitters.Social functioning (global assessment of functioning) improved in the sample as a whole from serious to mild impairment.Mean stimulation current was 2.86 ma; all side effects (strabismus at higher stimulation current, one small intracranial bleeding during surgery, infection at the implanted pulse generator site) could be resolved at short term.These preliminary findings suggest that bilateral stimulation of the supero-lateral branch of the medial forebrain bundle may significantly reduce symptoms in treatment-resistant major depressive disorder.Onset of antidepressant efficacy was rapid (days), and a higher proportion of the population responded at lower stimulation intensities than observed in previous studies.Reported events: patient 5: a (b)(6) female patient with deep brain stimulation (dbs) of the superolateral branch of the medial forebrain bundle (slmfb) for treatment-resistant depression (trd) experienced a small intracranial bleed during surgery of the first electrode with transient hemiparesis and dysarthria, which reportedly resolved after seven hours without complications.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.See attached literature article.

Manufacturer Narrative

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.

Manufacturer Narrative

Updated evaluation coding per new fda coding procedures.Additional information received via literature article.Coenen, v.A., sajonz, b., reisert, m., bostroem, j., bewernick, b., urbach, h., jenkner, c., reinacher, p.C., schlaepfer, t.E., madler, b.Tractography-assisted deep brain stimulation of the superolateral branch of the medial forebrain bundle (slmfb dbs) in major depression.Neuroimage: clinical.2018; 20: 580-593.Doi: 10.1016/j.Nicl.2018.08.020.If information is provided in the future, a supplemental report will be issued.

Event Description

Coenen, v.A., sajonz, b., reisert, m., bostroem, j., bewernick, b., urbach, h., jenkner, c., reinacher, p.C., schlaepfer, t.E., madler, b.Tractography-assisted deep brain stimulation of the superolateral branch of the medial forebrain bundle (slmfb dbs) in major depression.Neuroimage: clinical.2018; 20: 580-593.Doi: 10.1016/j.Nicl.2018.08.020.Additional information received from health care provider (hcp) via a literature article noted that the intracerebral hemorrhage was likely related to the micro-electrode recording performed during lead implant.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6538203
• MDR Text Key: 74216683
• Report Number: 3007566237-2017-01686
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2018
• 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): Other
• Patient Age: 48 YR