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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device deep brain stimulator for obsessive compulsive disorder (ocd)
Definition The device is indicated for bilateral stimulation of the anterior limb of the internal capsule, this device is indicated as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant Obsessive Compulsive Disorder (OCD) in adult patients who have failed at least three Selective Serotonin Reuptake Inhibitors (SSRIs).
Product CodeOLM
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2021 20 20
2022 30 30
2023 50 50
2024 39 40
2025 37 37
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 40 40
Connection Problem 38 38
Material Integrity Problem 35 35
Charging Problem 27 27
High impedance 25 25
Adverse Event Without Identified Device or Use Problem 22 22
Failure to Deliver Energy 21 21
Improper or Incorrect Procedure or Method 19 19
Communication or Transmission Problem 12 12
Insufficient Information 12 12
Therapeutic or Diagnostic Output Failure 10 10
Malposition of Device 7 7
Electromagnetic Compatibility Problem 7 7
Low impedance 7 7
Delayed Charge Time 7 7
Energy Output Problem 6 6
Failure to Interrogate 6 6
Impedance Problem 6 6
Failure to Power Up 5 5
Inappropriate/Inadequate Shock/Stimulation 5 6
Patient Device Interaction Problem 4 5
Overheating of Device 4 4
Display or Visual Feedback Problem 4 4
Material Frayed 3 3
Break 3 3
Migration or Expulsion of Device 3 3
Application Program Problem 2 2
Intermittent Continuity 2 2
Premature Discharge of Battery 2 2
Signal Artifact/Noise 1 1
Operating System Becomes Nonfunctional 1 1
Vibration 1 1
Positioning Problem 1 1
Shipping Damage or Problem 1 1
Environmental Compatibility Problem 1 1
Data Problem 1 1
Unintended Collision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 117 117
Insufficient Information 29 29
Unspecified Infection 13 13
Cognitive Changes 13 13
Electric Shock 7 8
Intracranial Hemorrhage 4 4
Anxiety 4 4
Depression 4 4
Pain 4 4
Sleep Dysfunction 3 3
Emotional Changes 3 3
Irritability 3 3
Burning Sensation 3 3
Dysphasia 2 2
Ambulation Difficulties 2 2
Constipation 2 2
Fatigue 2 2
Brain Injury 2 2
Headache 2 2
Hematoma 2 2
Erosion 2 2
Convulsion/Seizure 2 2
Post Operative Wound Infection 2 2
Paresthesia 2 2
Urinary Retention 2 2
Suicidal Ideation 2 2
Lethargy 1 1
Loss of consciousness 1 1
Neck Stiffness 1 1
Unspecified Tissue Injury 1 1
Shaking/Tremors 1 1
Tachycardia 1 1
Muscle Hypotonia 1 1
Pneumonia 1 1
Hypoglycemia 1 1
Fall 1 1
Chest Pain 1 1
Neck Pain 1 1
Fever 1 1
Device Overstimulation of Tissue 1 1
Cramp(s) /Muscle Spasm(s) 1 2
Dyskinesia 1 2
Tics/Tremor 1 1
Skin Inflammation/ Irritation 1 1
Dizziness 1 1
Memory Loss/Impairment 1 1
Wound Dehiscence 1 1
Impaired Healing 1 1
High Blood Pressure/ Hypertension 1 1

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