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

Model Number NEU_INS_STIMULATOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2014

Event Type  malfunction  

Manufacturer Narrative

The reported age reflects the average age of the patients reported in the literature article.Date of event: please note that this date is based off of the earliest listed trial date.The main component of the system and other applicable components are: product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.Events took place in both france and germany.If information is provided in the future, a supplemental report will be issued.

Event Description

Deuschl, g., vidailhet, m.The effect of deep brain stimulation of the subthalamic nucleus (stn-dbs) on quality of life in comparison to best medical treatment in patients with complicated parkinson¿s disease and preserved psychosocial competence (earlystim-study).2018.Summary: the post study follow-up study (psfu) of the earlystim study determine a common procedure for the follow-up period of the earlystim patients after the 24 months treatment period in germany and france.Patients, who were randomized to medical treatment (bmt [best medical treatment] group) in earlystim had the opportunity to undergo surgery after their 24 months¿ visit.The study was purely observational.The aim was to follow up patients who consented the psfu annually up to 5 years subsequent to fulfillment of the 24 months visit.Assessments were performed during regular annual follow-up visits.1.34 patients experienced dyskinesia.2.37 patients experienced depression.3.29 patients experienced tremor.4.24 patients experienced dysarthria.5.21 patients experienced freezing phenomenon.6.19 patients experienced weight increase.7.16 patients experienced dystonia.8.16 patients experienced parkinson's disease.9.13 patients experienced apathy.10.13 patients experienced fatigue.11.12 patients experienced bradykinesia.12.9 patients experienced gait disturbance.13.12 patients experienced sleep disorder.14.9 patients experienced akinesia.15.9 patients experienced impulsive behavior.16.9 patients experienced rapid eye movements sleep abnormal.17.8 patients experienced somnolence.18.7 patients experienced resting tremor.19.6 patients experienced balance disorder.20.5 patients experienced anxiety.21.5 patients experienced asthenia.22.5 patients experienced hyperkinesia.23.5 patients experienced hypomania.24.4 patients experienced medical device change.25.5 patients experienced muscle rigidity.26.5 patients experienced muscle spasms.27.5 patients experienced restless leg syndrome.28.2 patients experienced suicide attempt.29.4 patients experienced abnormal weight gain.30.4 patients experienced depressed mood.31.4 patients experienced headache.32.4 patients experienced hypokinesia.33.4 patients experienced insomnia.34.3 patients experienced nausea.35.6 patients experienced parkinsonian gait.36.3 patients experienced ballismus.37.4 patients experienced disturbance in attention.38.2 patients experienced dysphonia.39.3 patients experienced euphoric mood.40.2 patients experienced hallucination.41.3 patients experienced muscular weakness.42.3 patients experienced parkinsonism.43.3 patients experienced posture abnormal.44.3 patients experienced skin infection.45.3 patients experienced suicidal ideation.46.3 patients experienced weight decreased.47.2 patients experienced abnormal behavior.48.1 patients experienced abnormal dreams.49.2 patients experienced chest pain.50.2 patients experienced compulsive shopping.51.2 patients experienced convulsions.52.2 patients experienced coordination abnormal.53.2 patients experienced cough.54.3 patients experienced depressive symptoms.55.2 patients experienced dizziness.56.2 patients experienced general physical health deterioration.57.2 patients experienced hematoma.58.2 patients experienced implant site pain.59.2 patients experienced medical device complication.60.1 patient experienced mobility decrease.61.2 patients experienced orthostatic hypotension.62.1 patients experienced paresthesia.63.2 patients experienced pathological gambling.64.1 patient experienced affect liability.65.1 patient experienced affective disorder.66.1 patient experienced aggression.67.1 patient experienced agitation.68.1 patient experienced anxiety disorder.69.1 patient experienced ataxia.70.1 patient experienced blepharospasm.71.1 patient experienced brain abscess.72.1 patient experienced brain edema.73.1 patient experienced device battery issue.74.1 patient experienced device effect increased.75.1 patient experienced device failure.76.1 patient experienced device issue.77.1 patient experienced rapid eye movement sleep behavior disorder.78.1 patient experienced dysgeusia.79.1 patient experienced dysphagia.80.1 patient experienced fine motor delay.81.1 patient experienced gambling.82.1 patient experienced hemorrhage.83.1 patient experienced visual hallucination.84.1 patient experienced head titubation.85.1 patient experienced hypotonia.86.1 patient experienced implant site effusion.87.1 patient experienced implant site hematoma.88.1 patient experienced implant site paresthesia.89.1 patient experienced localized infection.90.2 patients experienced major depression.91.1 patient experienced meningioma.92.1 patient experienced migraine.93.1 patient experienced mood altered.94.1 patient experienced movement disorder.95.1 patient experienced muscle contractions involuntary.96.1 patient experienced musculoskeletal chest pain.97.1 patient experienced nuchal rigidity.98.1 patient experienced oromandibular dystonia.99.1 patient experienced photophobia.100.1 patient experienced post procedural hemorrhage.101.1 patient experienced presyncope.102.1 patient experienced procedural headache.103.1 patient experienced procedural pain.104.1 patient experienced psychomotor skills impaired.105.1 patient experienced psychosis postoperative.106.1 patient experienced scar pain.107.1 patient experienced slow speech.108.1 patient experienced speech disorder.109.1 patient experienced staphylococcal infection.110.1 patient experienced stereotypy.111.1 patient experienced application site hematoma.112.1 patient experienced transient ischemic attack.113.4 patients experienced device defective.114.1 patient experienced gambling disorder.115.1 patient experienced medical device dysesthesia.116.1 patient experienced medical device site reaction.117.1 patient experienced neuropsychiatric symptoms.118.1 patient experienced psychiatric decompensation.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• 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: 7526734
• MDR Text Key: 109115568
• Report Number: 3007566237-2018-01498
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/18/2018
• 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 Age: 52 YR