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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
2016 4 4
2017 7 7
2018 4 4
2019 16 16
2020 6 6
2021 20 20
2022 30 30
2023 50 50
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 38 38
Connection Problem 33 33
Material Integrity Problem 30 30
Battery Problem 29 29
High impedance 21 21
Charging Problem 18 18
Failure to Deliver Energy 13 13
Improper or Incorrect Procedure or Method 10 10
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 5 5
Impedance Problem 5 5
Therapeutic or Diagnostic Output Failure 5 5
Inappropriate/Inadequate Shock/Stimulation 4 4
Delayed Charge Time 3 3
Premature Discharge of Battery 3 3
Break 3 3
Material Frayed 3 3
Overheating of Device 2 2
Pocket Stimulation 2 2
Shipping Damage or Problem 2 2
Display or Visual Feedback Problem 2 2
Migration or Expulsion of Device 2 2
Unintended Collision 2 2
Vibration 2 2
Application Program Problem 2 2
Positioning Problem 2 2
Device Operates Differently Than Expected 2 2
Patient Device Interaction Problem 2 2
Appropriate Term/Code Not Available 2 2
Data Problem 1 1
Environmental Compatibility Problem 1 1
Power Problem 1 1
Signal Artifact/Noise 1 1
Disconnection 1 1
Off-Label Use 1 1
Peeled/Delaminated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 83 83
Cognitive Changes 23 23
Insufficient Information 18 18
No Known Impact Or Consequence To Patient 13 13
Unspecified Infection 13 13
Emotional Changes 10 10
Anxiety 10 10
Depression 10 10
Irritability 6 6
Electric Shock 6 6
Complaint, Ill-Defined 5 5
Pain 5 5
Therapeutic Response, Decreased 4 4
Headache 3 3
Intracranial Hemorrhage 3 3
Post Operative Wound Infection 3 3
Sleep Dysfunction 3 3
Ambulation Difficulties 2 2
Suicidal Ideation 2 2
Hematoma 2 2
Undesired Nerve Stimulation 2 2
Fall 2 2
Fatigue 2 2
Loss of consciousness 2 2
Muscular Tics 2 2
Dysphasia 2 2
Brain Injury 2 2
Dizziness 1 1
Seizures 1 1
Therapeutic Effects, Unexpected 1 1
Urinary Retention 1 1
Burning Sensation 1 1
Neck Pain 1 1
Neck Stiffness 1 1
Dyskinesia 1 1
Joint Dislocation 1 1
Fever 1 1
Bone Fracture(s) 1 1
Adhesion(s) 1 1
Erosion 1 1
Chest Pain 1 1
Death 1 1
Dehydration 1 1
Neurological Deficit/Dysfunction 1 1
Device Overstimulation of Tissue 1 1
Memory Loss/Impairment 1 1
Hypoglycemia 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Muscle Hypotonia 1 1
Lethargy 1 1
Shaking/Tremors 1 1
No Code Available 1 1
Convulsion/Seizure 1 1
Tics/Tremor 1 1

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