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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
2024 1 1

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
Low Battery 10 10
Break 10 10
Battery Problem 10 10
Charging Problem 8 8
Low impedance 8 8
Electromagnetic Compatibility Problem 7 7
Communication or Transmission Problem 6 6
Malposition of Device 6 6
Premature Discharge of Battery 6 6
Inappropriate/Inadequate Shock/Stimulation 5 5
Improper or Incorrect Procedure or Method 4 4
Delayed Charge Time 4 4
Insufficient Information 3 3
Material Deformation 3 3
Device Difficult to Program or Calibrate 3 3
Pocket Stimulation 2 2
Connection Problem 2 2
Appropriate Term/Code Not Available 2 2
Overheating of Device 2 2
Therapy Delivered to Incorrect Body Area 2 2
Patient Device Interaction Problem 2 2
Unstable 2 2
Failure to Power Up 2 2
Human-Device Interface Problem 1 1
Electromagnetic Interference 1 1
Nonstandard Device 1 1
Device Damaged by Another Device 1 1
Loss of Data 1 1
Impedance Problem 1 1
Noise, Audible 1 1
No Device Output 1 1
Unintended Collision 1 1
Material Integrity Problem 1 1
Positioning Problem 1 1
Energy Output To Patient Tissue Incorrect 1 1
Output Problem 1 1
Disconnection 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 9 9
Dysphasia 8 8
Pain 8 8
Fracture, Arm 7 7
Insufficient Information 7 7
Bone Fracture(s) 7 7
Erythema 6 6
Inflammation 6 6
Sleep Dysfunction 5 5
Electric Shock 5 5
Distress 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Nausea 4 4
Seizures, Focal 4 4
Seizures 4 4
Undesired Nerve Stimulation 3 3
No Code Available 3 3
Dyskinesia 3 3
Twiddlers Syndrome 3 3
Fatigue 3 3
Vertigo 3 3
Muscular Rigidity 3 3
Swelling 3 3
Apnea 3 3
Seizures, Absence 3 3
Bacterial Infection 2 2
Irritability 2 2
Loss of consciousness 2 2
Weight Changes 2 2
Hypersensitivity/Allergic reaction 2 2
Tingling 2 2
Abscess 2 2
Paresis 2 2
Hemorrhage, Cerebral 2 2
Death 2 2
Muscle Spasm(s) 2 2
Intracranial Hemorrhage 2 2
Visual Disturbances 2 2
Burning Sensation 2 2
Seizures, Grand-Mal 2 2
Test Result 2 2

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