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

Model Number NEU_INS_STIMULATOR

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

Patient Problems Memory Loss/Impairment (1958); Dysphasia (2195); Anxiety (2328); Depression (2361); Dyskinesia (2363); Irritability (2421); Cognitive Changes (2551); Confusion/ Disorientation (2553); Tics/Tremor (4425); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/26/2009

Event Type  Injury  

Manufacturer Narrative

Camprodon ja, chou t, testo aa, deckersbach t, scharf jm, dougherty dd.Case report: deep brain stimulation to the ventral internal capsule/ventral striatum induces repeated transient episodes of voltage-dependent tourette-like behaviors.Front hum neurosci.2020 ;14:590379.10.3389/fnhum.2020.590379.Date of event: 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.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.Common device name,pma/510k: please note that this device was used in an off-label manner as it was implanted for depression.If information is provided in the future, a supplemental report will be issued.

Event Description

Reported event: a (b)(6) year old caucasian male implanted with bilateral ventral internal capsule/ventral striatum (vc/vs) deep brain stimulation (dbs) for severe treatment resistant major depressive disorder (mdd) experienced tourette-like behaviors associated with stimulation.The patient experienced worsened depressive symptoms 16 weeks prior to hospital admission, and resumed drinking up to four mixed drinks per day around this time.At two weeks prior to admission, the patient experienced brief episodes (20 seconds to 2 minutes) of garbled, nonsensical speech with paraphrasias, neologisms, agrammatism, coprolalia, rushes of anger and anxiety without panic symptoms, and motor automatisms on the right arm and leg.A day prior to admission, the patient contacted the physicians who advised turning the dbs off prior to presentation to clinic.The patient was seen the following day at outpatient clinic and was referred to neurology service.Neuro exam was normal with dbs turned.Tia/stroke workup with brain ct, cta of brain and neck, tte, and 24 hour holter were negative.Lipid panel hemoglobin a1c, vitamin b12, thiamine, tsh, urine drug screen and blood alcohol level were normal.There was negative workup for seizures with eeg with dbs off (and later on), and there were two possible but unclear events with no epileptiform activity during 24 hour long eeg monitoring.After turning dbs on, there were short episodes of progressively faster and louder stuttering with previously mentioned symptoms and right sided tic-like motor automatisms, ego-dystonic "rush" of physical and psychological activation.The patient had minimal memory of these events afterwards.The patient was always conscious during these events, but had minimal awareness or memory of the events even after they occurred.He had mild confusion after the events, but was alert and oriented, and was lacking good recollection of the details.Further examination revealed brief transient episodic amnesia leading to a discontinuous perception of both external and internal events.During one event, he continued drawing circles on a paper in what seemed to be a mix of jerk-like movements and transient perseveration.The voltage of the device was increased from 7 to 8 v with no changes, and then to 8.5 v which immediately started an event and ceased with voltage reduced to 7 v.Patient was discharged and scheduled to follow-up with neurotherapeutics team.One day later the patient presented back at outpatient clinic.Device was turned on and pulse width was decreased to 90 usec of the left electrode with voltage left at 9 v.The patient reported no side effects and left with safety plan.At 3 weeks post-discharge, the patient reported a few brief similar episodes, and he was advised to turn dbs off.Outpatient eeg with device on at higher intensity led to immediate induction of an event with no signs of epileptiform activity.Eeg remained unchanged even when intensity reduced and behavioral effects disappeared.Dbs was turned on and left with same low pulse width and voltage was reduced to 5 v.Closer radiographic analysis of the dbs lead position revealed the left lead was observed to be more ventral and rostral than the right.Pet imaging was used to measure brain perfusion and data was analyzed to identify specific brain perfusion patterns associated with the iatrogenic dbs location.Dbs stimulation with the iatrogenic montage compared to monopolar configuration at contact 3 led to significant perfusion in the insula, pallidum, and anterior cingulate.Per the authors, the pet results supported the hypothesis that maladaptive dbs activation of functional circuits caused these events: d bs of the ventral-anterior vc/vs (which elicited the aberrant behaviors) led to increased perfusion in a circuit of regions involving the insula, basal ganglia, and the anterior cingulate, compared to a more dorsal vc/vs configuration that did not elicit symptoms.Active electrode on left side system were changed to a more dorsal position to match the position of the right active electrode, and voltage was slowly titrated up to 7.5 v bilaterally over several weeks.No side effects had been reported since, but the patient's depressive symptoms had worsened and he lost initial beneficial response from dbs.The patient was eventually explanted given lack of efficacy, poor compliance with follow-up visits and new medical comorbidities that could be more effectively and safely monitored using mri without limitations associated with an implanted medical device.Relevant medical history included mdd, panic attacks, vagus nerve stimulation (later explanted), electroconvulsive therapy (ect), post-ect confusion and encephalopathy, radioablative treatment for lumbar spondylosis, and alcohol abuse/dependence.No device information could be identified in the literature article.

Manufacturer Narrative

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

Additional information was received.The patient also experienced dysarthria, dyskinesia and brief periods of disinhibition (cursing, driving fast).Work-up for transient ischemic attacks (tias) and seizures were negative, although the authors noted it was possible that the symptoms experienced were seizure related.As the symptoms returned when the dbs was turned back on, the er staff and study team concluded it was most likely related to stimulation, specifically a recent increase in pulse width from 90 to 210 usec.The pulsewidth was lowered prior to discharge.Medication: nardil 75mg per day, alprazolam 5mg per day.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 11631965
• MDR Text Key: 260990438
• Report Number: 2182207-2021-00601
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR