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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 16 16

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 116 116
No Device Output 104 104
Migration 79 79
Insufficient Information 62 62
Device Appears to Trigger Rejection 60 60
Break 7 7
Extrusion 7 7
Improper or Incorrect Procedure or Method 6 6
Device Dislodged or Dislocated 5 5
Appropriate Term/Code Not Available 5 5
Noise, Audible 4 4
Device Stops Intermittently 4 4
Device Inoperable 3 3
Lack of Effect 3 3
Device Handling Problem 3 3
Positioning Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Malposition of Device 3 3
Intermittent Continuity 2 2
Degraded 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Circuit Failure 1 1
Air Leak 1 1
No Audible Alarm 1 1
Fitting Problem 1 1
No Audible Prompt/Feedback 1 1
Cut In Material 1 1
Ambient Noise Problem 1 1
Capturing Problem 1 1
Escape 1 1
Improper Device Output 1 1
Output below Specifications 1 1
Intermittent Energy Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 450 450
Hearing Loss 69 69
Skin Tears 28 28
No Code Available 26 26
Tissue Damage 25 25
No Information 24 24
No Known Impact Or Consequence To Patient 22 22
Insufficient Information 21 21
Hearing Impairment 19 19
Unspecified Infection 18 18
No Clinical Signs, Symptoms or Conditions 16 16
Tissue Breakdown 15 15
Therapeutic Response, Decreased 15 15
Therapeutic Effects, Unexpected 8 8
Pain 7 7
Bacterial Infection 7 7
Head Injury 6 6
Implant Pain 5 5
Total Hearing Loss 5 5
Fall 4 4
Wound Dehiscence 4 4
Complaint, Ill-Defined 4 4
Pressure Sores 3 3
Deafness 3 3
Erosion 2 2
Headache 2 2
Idioventricular Rhythm 2 2
Discomfort 2 2
Impaired Healing 2 2
Necrosis 2 2
Skin Infection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Shock from Patient Lead(s) 1 1
Partial Hearing Loss 1 1
Undesired Nerve Stimulation 1 1
Scar Tissue 1 1
Swelling 1 1
Vertigo 1 1
Perforation of Vessels 1 1
Blurred Vision 1 1
No Consequences Or Impact To Patient 1 1
Meningitis 1 1
Patient Problem/Medical Problem 1 1
Tinnitus 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Inflammation 1 1
Irritation 1 1
Granuloma 1 1

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