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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, brain, implanted, for behavior modification
Product CodeMFR
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2014 30 30
2015 71 71
2016 51 51
2017 24 24
2018 7 7
2020 5 5
2021 9 9
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 86 86
Device Operates Differently Than Expected 30 30
High impedance 24 24
Device Displays Incorrect Message 14 14
Failure to Deliver Energy 13 13
Intermittent Continuity 12 12
Migration or Expulsion of Device 11 11
Break 10 10
Low Battery 10 10
Battery Problem 10 10
Charging Problem 8 8
Low impedance 8 8
Electromagnetic Compatibility Problem 7 7
Malposition of Device 6 6
Communication or Transmission Problem 6 6
Premature Discharge of Battery 6 6
Inappropriate/Inadequate Shock/Stimulation 5 5
Delayed Charge Time 4 4
Improper or Incorrect Procedure or Method 4 4
Material Deformation 3 3
Device Difficult to Program or Calibrate 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 2 2
Patient Device Interaction Problem 2 2
Therapy Delivered to Incorrect Body Area 2 2
Unstable 2 2
Overheating of Device 2 2
Pocket Stimulation 2 2
Failure to Power Up 2 2
Connection Problem 2 2
Loss of Data 1 1
Material Integrity Problem 1 1
Human-Device Interface Problem 1 1
Impedance Problem 1 1
Device Damaged by Another Device 1 1
Nonstandard Device 1 1
Unintended Collision 1 1
No Device Output 1 1
Disconnection 1 1
Electromagnetic Interference 1 1
Energy Output To Patient Tissue Incorrect 1 1
Noise, Audible 1 1
Output Problem 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 44 44
Cognitive Changes 41 41
Therapeutic Effects, Unexpected 35 35
Complaint, Ill-Defined 34 34
Depression 24 24
Therapeutic Response, Decreased 23 23
Unspecified Infection 19 19
Anxiety 16 16
Emotional Changes 13 13
Headache 8 8
Dysphasia 8 8
Fracture, Arm 7 7
Pain 7 7
Bone Fracture(s) 7 7
Insufficient Information 7 7
Erythema 6 6
Inflammation 6 6
Sleep Dysfunction 5 5
Electric Shock 5 5
Seizures, Focal 4 4
Distress 4 4
Nausea 4 4
Seizures 4 4
No Clinical Signs, Symptoms or Conditions 4 4
No Code Available 3 3
Undesired Nerve Stimulation 3 3
Fatigue 3 3
Muscular Rigidity 3 3
Apnea 3 3
Twiddlers Syndrome 3 3
Vertigo 3 3
Seizures, Absence 3 3
Dyskinesia 3 3
Swelling 3 3
Weight Changes 2 2
Test Result 2 2
Loss of consciousness 2 2
Irritability 2 2
Paresis 2 2
Visual Disturbances 2 2
Burning Sensation 2 2
Seizures, Grand-Mal 2 2
Tingling 2 2
Bacterial Infection 2 2
Abscess 2 2
Death 2 2
Hemorrhage, Cerebral 2 2
Intracranial Hemorrhage 2 2
Hypersensitivity/Allergic reaction 2 2
Memory Loss/Impairment 2 2
Muscle Spasm(s) 2 2
Irritation 1 1
Itching Sensation 1 1
Device Overstimulation of Tissue 1 1
Nerve Damage 1 1
Seizures, Focal Motor 1 1
Seroma 1 1
Skin Erosion 1 1
Failure of Implant 1 1
Head Injury 1 1
Hematoma 1 1
Purulent Discharge 1 1
Edema 1 1
Fainting 1 1
Adhesion(s) 1 1
Erosion 1 1
Dizziness 1 1
Muscular Tics 1 1
Discomfort 1 1
Staphylococcus Aureus 1 1
Transient Ischemic Attack 1 1
Blurred Vision 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Skin Inflammation 1 1
Disability 1 1
Confusion/ Disorientation 1 1
Convulsion/Seizure 1 1

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