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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
2019 16 16
2020 6 6
2021 20 20
2022 30 30
2023 50 50
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 33 33
Material Integrity Problem 30 30
Adverse Event Without Identified Device or Use Problem 29 29
Battery Problem 28 28
Charging Problem 18 18
High impedance 16 16
Failure to Deliver Energy 12 12
Improper or Incorrect Procedure or Method 9 9
Insufficient Information 9 9
Electromagnetic Compatibility Problem 7 7
Communication or Transmission Problem 6 6
Energy Output Problem 6 6
Failure to Power Up 5 5
Failure to Interrogate 5 5
Malposition of Device 5 5
Low impedance 4 4
Impedance Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Premature Discharge of Battery 3 3
Material Frayed 3 3
Inappropriate/Inadequate Shock/Stimulation 2 2
Vibration 2 2
Display or Visual Feedback Problem 2 2
Migration or Expulsion of Device 2 2
Unintended Collision 2 2
Delayed Charge Time 2 2
Application Program Problem 2 2
Patient Device Interaction Problem 2 2
Environmental Compatibility Problem 1 1
Data Problem 1 1
Positioning Problem 1 1
Power Problem 1 1
Signal Artifact/Noise 1 1
Break 1 1
Disconnection 1 1
Shipping Damage or Problem 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 80 80
Insufficient Information 18 18
Cognitive Changes 17 17
Unspecified Infection 13 13
Anxiety 9 9
Depression 7 7
Emotional Changes 7 7
Irritability 6 6
Pain 5 5
No Known Impact Or Consequence To Patient 5 5
Therapeutic Response, Decreased 4 4
Electric Shock 4 4
Sleep Dysfunction 3 3
Post Operative Wound Infection 3 3
Intracranial Hemorrhage 3 3
Headache 3 3
Hematoma 2 2
Fall 2 2
Fatigue 2 2
Ambulation Difficulties 2 2
Complaint, Ill-Defined 2 2
Muscular Tics 2 2
Dysphasia 2 2
Brain Injury 2 2
Suicidal Ideation 2 2
Unspecified Mental, Emotional or Behavioural Problem 1 1
Muscle Hypotonia 1 1
No Code Available 1 1
Convulsion/Seizure 1 1
Tics/Tremor 1 1
Dizziness 1 1
Joint Dislocation 1 1
Loss of consciousness 1 1
Lethargy 1 1
Shaking/Tremors 1 1
Neck Pain 1 1
Neck Stiffness 1 1
Fever 1 1
Bone Fracture(s) 1 1
Adhesion(s) 1 1
Erosion 1 1
Chest Pain 1 1
Hypoglycemia 1 1
Memory Loss/Impairment 1 1
Device Overstimulation of Tissue 1 1
Seizures 1 1
Therapeutic Effects, Unexpected 1 1
Urinary Retention 1 1

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