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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 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 38 38
Connection Problem 34 34
Material Integrity Problem 31 31
Battery Problem 29 29
High impedance 22 22
Charging Problem 20 20
Failure to Deliver Energy 14 14
Improper or Incorrect Procedure or Method 10 10
Insufficient Information 9 9
Communication or Transmission Problem 8 8
Electromagnetic Compatibility Problem 7 7
Malposition of Device 6 6
Energy Output Problem 6 6
Inappropriate/Inadequate Shock/Stimulation 5 5
Low impedance 5 5
Impedance Problem 5 5
Therapeutic or Diagnostic Output Failure 5 5
Failure to Interrogate 5 5
Failure to Power Up 5 5
Patient Device Interaction Problem 3 3
Premature Discharge of Battery 3 3
Delayed Charge Time 3 3
Break 3 3
Material Frayed 3 3
Positioning Problem 2 2
Vibration 2 2
Shipping Damage or Problem 2 2
Appropriate Term/Code Not Available 2 2
Application Program Problem 2 2
Device Operates Differently Than Expected 2 2
Pocket Stimulation 2 2
Overheating of Device 2 2
Display or Visual Feedback Problem 2 2
Unintended Collision 2 2
Migration or Expulsion of Device 2 2
Peeled/Delaminated 1 1
Power Problem 1 1
Disconnection 1 1
Signal Artifact/Noise 1 1
Environmental Compatibility Problem 1 1
Data Problem 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 87 87
Cognitive Changes 24 24
Insufficient Information 19 19
Unspecified Infection 13 13
No Known Impact Or Consequence To Patient 13 13
Anxiety 10 10
Emotional Changes 10 10
Depression 10 10
Electric Shock 7 7
Irritability 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
Hematoma 2 2
Brain Injury 2 2
Suicidal Ideation 2 2
Fall 2 2
Fatigue 2 2
Undesired Nerve Stimulation 2 2
Muscular Tics 2 2
Loss of consciousness 2 2
Dysphasia 2 2
Ambulation Difficulties 2 2
Bone Fracture(s) 1 1
Tics/Tremor 1 1
Dyskinesia 1 1
Adhesion(s) 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Neurological Deficit/Dysfunction 1 1
Device Overstimulation of Tissue 1 1
Dizziness 1 1
Memory Loss/Impairment 1 1
Fever 1 1
No Code Available 1 1
Burning Sensation 1 1
Neck Pain 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Chest Pain 1 1
Urinary Retention 1 1
Seizures 1 1
Dehydration 1 1
Hypoglycemia 1 1
Muscle Hypotonia 1 1
Joint Dislocation 1 1
Shaking/Tremors 1 1
Death 1 1

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