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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, hearing, active, middle ear, partially implanted
Product CodeMPV
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
2 4 3 1 2 1 1 2 0 0 0 1 0 1 0 0

MDR Year MDR Reports MDR Events
2014 112 112
2015 80 80
2016 65 65
2017 44 44
2018 53 53
2019 41 41
2020 54 54
2021 69 69
2022 57 57
2023 68 68
2024 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 193 193
Device Operates Differently Than Expected 192 192
Adverse Event Without Identified Device or Use Problem 120 120
No Device Output 118 118
Migration 85 85
Insufficient Information 69 69
Device Appears to Trigger Rejection 64 64
Extrusion 7 7
Break 7 7
Improper or Incorrect Procedure or Method 6 6
Positioning Problem 5 5
Lack of Effect 5 5
Noise, Audible 5 5
Appropriate Term/Code Not Available 5 5
Device Dislodged or Dislocated 5 5
Device Stops Intermittently 4 4
Malposition of Device 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Handling Problem 3 3
Device Inoperable 3 3
Intermittent Continuity 2 2
Improper Device Output 1 1
Fitting Problem 1 1
Circuit Failure 1 1
Cut In Material 1 1
Incomplete or Inadequate Connection 1 1
Migration or Expulsion of Device 1 1
Mechanical Problem 1 1
Intermittent Energy Output 1 1
No Audible Alarm 1 1
No Audible Prompt/Feedback 1 1
Ambient Noise Problem 1 1
Capturing Problem 1 1
Air Leak 1 1
Degraded 1 1
Escape 1 1
Output below Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 476 476
Hearing Loss 69 69
Skin Tears 30 30
No Code Available 26 26
Tissue Damage 25 25
No Information 24 24
Insufficient Information 23 23
No Known Impact Or Consequence To Patient 22 22
No Clinical Signs, Symptoms or Conditions 21 21
Unspecified Infection 19 19
Hearing Impairment 19 19
Tissue Breakdown 17 17
Therapeutic Response, Decreased 15 15
Bacterial Infection 8 8
Therapeutic Effects, Unexpected 8 8
Pain 7 7
Head Injury 6 6
Total Hearing Loss 5 5
Implant Pain 5 5
Complaint, Ill-Defined 4 4
Wound Dehiscence 4 4
Fall 4 4
Deafness 3 3
Pressure Sores 3 3
Discomfort 3 3
Headache 2 2
Erosion 2 2
Necrosis 2 2
Idioventricular Rhythm 2 2
Skin Infection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Impaired Healing 2 2
Scar Tissue 1 1
Vertigo 1 1
Swelling 1 1
Partial Hearing Loss 1 1
Undesired Nerve Stimulation 1 1
Perforation of Vessels 1 1
Irritation 1 1
Blurred Vision 1 1
Inflammation 1 1
Hematoma 1 1
Tinnitus 1 1
No Consequences Or Impact To Patient 1 1
Hemorrhage/Bleeding 1 1
Shock from Patient Lead(s) 1 1
Meningitis 1 1
Granuloma 1 1
Patient Problem/Medical Problem 1 1

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