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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)
2016 2017 2018 2019 2020 2021 2022 2023 2024
2 0 0 0 1 0 1 0 0

MDR Year MDR Reports MDR Events
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 188 188
Device Operates Differently Than Expected 117 117
Migration 85 85
Adverse Event Without Identified Device or Use Problem 84 84
Device Appears to Trigger Rejection 63 63
No Device Output 62 62
Insufficient Information 47 47
Lack of Effect 5 5
Improper or Incorrect Procedure or Method 3 3
Positioning Problem 2 2
Noise, Audible 2 2
Device Handling Problem 2 2
Malposition of Device 2 2
Circuit Failure 1 1
Intermittent Energy Output 1 1
Intermittent Continuity 1 1
Incomplete or Inadequate Connection 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 425 425
Skin Tears 30 30
Tissue Damage 24 24
Insufficient Information 22 22
No Clinical Signs, Symptoms or Conditions 21 21
Tissue Breakdown 17 17
Unspecified Infection 11 11
No Information 9 9
Bacterial Infection 8 8
Total Hearing Loss 5 5
Head Injury 5 5
Implant Pain 5 5
Wound Dehiscence 4 4
No Known Impact Or Consequence To Patient 4 4
Pain 4 4
Pressure Sores 3 3
Impaired Healing 2 2
Skin Infection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hearing Loss 2 2
Necrosis 2 2
Discomfort 2 2
Headache 2 2
Hearing Impairment 1 1
Patient Problem/Medical Problem 1 1
Idioventricular Rhythm 1 1
Inflammation 1 1
Irritation 1 1
Vertigo 1 1
Partial Hearing Loss 1 1
Undesired Nerve Stimulation 1 1
Perforation of Vessels 1 1
Therapeutic Effects, Unexpected 1 1
Meningitis 1 1
Granuloma 1 1
Deafness 1 1

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