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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implanted brain stimulator for epilepsy
Definition For the treatment of epilepsy.
Product CodePFN
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 3 22 13 8 4 10 12 8 3 3 4 1

MDR Year MDR Reports MDR Events
2014 15 15
2015 36 36
2016 28 28
2017 63 63
2018 54 54
2019 59 59
2020 66 66
2021 57 57
2022 49 49
2023 67 67
2024 69 69

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 404 404
Signal Artifact/Noise 49 49
Impedance Problem 37 37
High impedance 34 34
Break 33 33
Failure to Interrogate 27 27
Communication or Transmission Problem 20 20
Insufficient Information 19 19
Premature Discharge of Battery 10 10
Appropriate Term/Code Not Available 7 7
Failure to Transmit Record 6 6
Device Remains Activated 5 5
Fracture 5 5
Battery Problem 4 4
Positioning Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unexpected Therapeutic Results 2 2
Deformation Due to Compressive Stress 2 2
Leak/Splash 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Off-Label Use 1 1
Material Erosion 1 1
Material Fragmentation 1 1
Dent in Material 1 1
Mechanics Altered 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Installation-Related Problem 1 1
Programming Issue 1 1
Missing Value Reason 1 1
Migration 1 1
Under-Sensing 1 1
Low impedance 1 1
Electrical /Electronic Property Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of Data 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bacterial Infection 132 132
Unspecified Infection 119 119
No Clinical Signs, Symptoms or Conditions 64 64
No Consequences Or Impact To Patient 52 52
Wound Dehiscence 50 50
Erosion 40 40
Fluid Discharge 40 40
Impaired Healing 27 27
Purulent Discharge 24 24
Hemorrhage/Bleeding 22 22
Pain 22 22
Headache 21 21
Hematoma 19 19
Drug Resistant Bacterial Infection 17 17
Intracranial Hemorrhage 16 16
Skin Erosion 13 13
No Known Impact Or Consequence To Patient 11 11
Swelling/ Edema 10 10
No Code Available 10 10
Discharge 10 10
Edema 9 9
Seizures 7 7
Fever 7 7
Cerebrospinal Fluid Leakage 6 6
Head Injury 6 6
Discomfort 6 6
Stroke/CVA 6 6
Staphylococcus Aureus 6 6
Post Operative Wound Infection 6 6
Muscle Weakness 5 5
Swelling 5 5
Visual Impairment 4 4
Twiddlers Syndrome 4 4
Injury 4 4
Hemorrhage, Subdural 4 4
Hydrocephalus 3 3
Abscess 3 3
Fall 3 3
Convulsion/Seizure 3 3
Weakness 3 3
Cerebral Edema 3 3
Sleep Dysfunction 3 3
Patient Problem/Medical Problem 3 3
Speech Disorder 3 3
Emotional Changes 3 3
Neuropathy 2 2
Confusion/ Disorientation 2 2
Skin Discoloration 2 2
Cellulitis 2 2
Loss of Vision 2 2

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