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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 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 34 34
Material Integrity Problem 31 31
Battery Problem 29 29
Adverse Event Without Identified Device or Use Problem 29 29
High impedance 20 20
Charging Problem 20 20
Failure to Deliver Energy 14 14
Insufficient Information 9 9
Improper or Incorrect Procedure or Method 9 9
Communication or Transmission Problem 8 8
Electromagnetic Compatibility Problem 7 7
Malposition of Device 6 6
Energy Output Problem 6 6
Failure to Interrogate 5 5
Therapeutic or Diagnostic Output Failure 5 5
Failure to Power Up 5 5
Impedance Problem 4 4
Low impedance 4 4
Material Frayed 3 3
Patient Device Interaction Problem 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Premature Discharge of Battery 3 3
Delayed Charge Time 3 3
Migration or Expulsion of Device 2 2
Application Program Problem 2 2
Vibration 2 2
Overheating of Device 2 2
Display or Visual Feedback Problem 2 2
Unintended Collision 2 2
Signal Artifact/Noise 1 1
Disconnection 1 1
Break 1 1
Positioning Problem 1 1
Shipping Damage or Problem 1 1
Environmental Compatibility Problem 1 1
Data Problem 1 1
Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 87 87
Insufficient Information 19 19
Cognitive Changes 18 18
Unspecified Infection 13 13
Anxiety 9 9
Emotional Changes 7 7
Depression 7 7
Irritability 6 6
Electric Shock 5 5
No Known Impact Or Consequence To Patient 5 5
Pain 5 5
Therapeutic Response, Decreased 4 4
Sleep Dysfunction 3 3
Headache 3 3
Post Operative Wound Infection 3 3
Intracranial Hemorrhage 3 3
Dysphasia 2 2
Complaint, Ill-Defined 2 2
Fatigue 2 2
Ambulation Difficulties 2 2
Brain Injury 2 2
Hematoma 2 2
Muscular Tics 2 2
Suicidal Ideation 2 2
Fall 2 2
Lethargy 1 1
Loss of consciousness 1 1
Therapeutic Effects, Unexpected 1 1
Erosion 1 1
Convulsion/Seizure 1 1
Neck Stiffness 1 1
Shaking/Tremors 1 1
Muscle Hypotonia 1 1
Hypoglycemia 1 1
Urinary Retention 1 1
Chest Pain 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Neck Pain 1 1
Burning Sensation 1 1
Fever 1 1
Device Overstimulation of Tissue 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Tics/Tremor 1 1
Bone Fracture(s) 1 1
Adhesion(s) 1 1
Dizziness 1 1
Memory Loss/Impairment 1 1
No Code Available 1 1
Seizures 1 1
Joint Dislocation 1 1

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