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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
2020 5 5
2021 9 9
2022 1 1
2023 2 2
2024 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Insufficient Information 3 3
Failure to Deliver Energy 2 2
High impedance 2 2
Communication or Transmission Problem 2 2
Output Problem 2 2
Patient Device Interaction Problem 2 2
Failure to Power Up 2 2
Charging Problem 2 2
Electromagnetic Compatibility Problem 2 2
Intermittent Continuity 2 2
Break 1 1
Migration or Expulsion of Device 1 1
Use of Device Problem 1 1
Low impedance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 7 7
Unspecified Infection 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Cognitive Changes 3 3
Pain 3 3
Headache 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Complaint, Ill-Defined 1 1
Failure of Implant 1 1
Adhesion(s) 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Blister 1 1
Incontinence 1 1
Depression 1 1
Abscess 1 1
Anxiety 1 1
Convulsion/Seizure 1 1
Irritability 1 1

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