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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, cochlear
Product CodeMCM
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
35 25 20 24 18 3

MDR Year MDR Reports MDR Events
2019 3406 3406
2020 4403 4403
2021 5260 5260
2022 5501 5501
2023 5730 5730
2024 1451 1451

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 5846 5846
Mechanical Problem 5002 5002
Impedance Problem 4083 4083
Adverse Event Without Identified Device or Use Problem 4065 4065
Output Problem 4065 4065
Expulsion 1497 1497
Migration 1391 1391
Insufficient Information 1267 1267
Therapeutic or Diagnostic Output Failure 960 960
Circuit Failure 717 717
Device Dislodged or Dislocated 510 510
No Device Output 486 486
Positioning Failure 369 369
Device Appears to Trigger Rejection 331 331
Migration or Expulsion of Device 301 301
Intermittent Communication Failure 288 288
Unexpected Therapeutic Results 272 272
Material Protrusion/Extrusion 269 269
Output below Specifications 222 222
Fluid/Blood Leak 179 179
Patient Device Interaction Problem 173 173
No Apparent Adverse Event 148 148
Electrical /Electronic Property Problem 143 143
Malposition of Device 115 115
Loose or Intermittent Connection 96 96
Patient-Device Incompatibility 94 94
Electrical Shorting 86 86
Electro-Static Discharge 85 85
Positioning Problem 77 77
Melted 69 69
Failure to Read Input Signal 68 68
Battery Problem 62 62
Inadequacy of Device Shape and/or Size 54 54
High impedance 53 53
Device Handling Problem 51 51
Connection Problem 49 49
Noise, Audible 47 47
Overheating of Device 38 38
Improper or Incorrect Procedure or Method 38 38
No Audible Prompt/Feedback 38 38
Device Slipped 37 37
Communication or Transmission Problem 37 37
Microbial Contamination of Device 32 32
Product Quality Problem 25 25
Misconnection 23 23
Application Program Version or Upgrade Problem 23 23
Sparking 22 22
Leak/Splash 22 22
Thermal Decomposition of Device 22 22
Incorrect, Inadequate or Imprecise Result or Readings 22 22
Use of Device Problem 22 22
Difficult to Insert 20 20
Operating System Version or Upgrade Problem 20 20
Failure to Deliver Shock/Stimulation 19 19
Defective Device 18 18
Lack of Effect 18 18
Unintended Movement 17 17
Break 17 17
Detachment of Device or Device Component 14 14
Application Program Problem 13 13
Low impedance 13 13
Biocompatibility 11 11
Unintended Electrical Shock 10 10
Structural Problem 10 10
Loosening of Implant Not Related to Bone-Ingrowth 9 9
Material Deformation 8 8
Intermittent Shock/Stimulation 8 8
Defective Component 8 8
Signal Artifact/Noise 8 8
Intermittent Continuity 8 8
Fracture 8 8
Inaudible or Unclear Audible Prompt/Feedback 7 7
Energy Output Problem 6 6
Fitting Problem 6 6
Increased Sensitivity 6 6
Crack 6 6
Device Unsafe to Use in Environment 6 6
Device Tipped Over 6 6
Decreased Sensitivity 5 5
Audible Prompt/Feedback Problem 5 5
Burst Container or Vessel 5 5
Loss of Osseointegration 5 5
Premature Discharge of Battery 4 4
Corroded 4 4
Fire 4 4
Disconnection 4 4
Intermittent Loss of Power 4 4
Material Twisted/Bent 4 4
Device-Device Incompatibility 4 4
Fail-Safe Problem 4 4
Failure of Device to Self-Test 4 4
Activation, Positioning or Separation Problem 3 3
Contamination /Decontamination Problem 3 3
Physical Resistance/Sticking 3 3
Device Fell 3 3
Program or Algorithm Execution Problem 3 3
Electromagnetic Interference 3 3
Difficult or Delayed Positioning 3 3
Computer Software Problem 3 3
Defibrillation/Stimulation Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7565 7565
Failure of Implant 6367 6367
Insufficient Information 2875 2875
Unspecified Infection 2424 2424
No Clinical Signs, Symptoms or Conditions 1996 1996
Pain 1434 1434
Hearing Impairment 1155 1155
No Code Available 910 910
Tissue Breakdown 846 846
Head Injury 597 597
Therapeutic Response, Decreased 557 557
No Known Impact Or Consequence To Patient 533 533
Swelling/ Edema 377 377
Skin Infection 376 376
No Information 369 369
Wound Dehiscence 357 357
Bacterial Infection 347 347
Undesired Nerve Stimulation 302 302
Implant Pain 239 239
Patient Problem/Medical Problem 238 238
Dizziness 223 223
Discomfort 201 201
Necrosis 198 198
Headache 187 187
Skin Inflammation/ Irritation 174 174
Post Operative Wound Infection 166 166
Tinnitus 150 150
Swelling 147 147
Inflammation 141 141
Meningitis 119 119
Purulent Discharge 103 103
Fluid Discharge 91 91
Vertigo 87 87
Erythema 81 81
Hematoma 78 78
Abscess 77 77
Skin Tears 76 76
Therapeutic Effects, Unexpected 75 75
Drug Resistant Bacterial Infection 64 64
Cerebrospinal Fluid Leakage 61 61
Impaired Healing 58 58
Skin Erosion 56 56
Ulcer 52 52
Ossification 49 49
Tissue Damage 40 40
Fall 37 37
Cellulitis 35 35
Erosion 31 31
Burning Sensation 30 30
No Consequences Or Impact To Patient 29 29
Granuloma 28 28
Seroma 27 27
Discharge 26 26
Electric Shock 25 25
Skin Irritation 24 24
Inadequate Pain Relief 22 22
Edema 22 22
Necrosis Of Flap Tissue 22 22
Hearing Loss 18 18
Fistula 18 18
No Patient Involvement 18 18
Nausea 17 17
Staphylococcus Aureus 17 17
Hemorrhage/Bleeding 16 16
Hypersensitivity/Allergic reaction 15 15
Cyst(s) 15 15
Deafness 14 14
Facial Nerve Paralysis 13 13
Fibrosis 12 12
Vomiting 11 11
Fever 11 11
Paralysis 11 11
Itching Sensation 11 11
Irritation 10 10
Scar Tissue 10 10
Post Traumatic Wound Infection 10 10
Skin Burning Sensation 10 10
Total Hearing Loss 9 9
Shock 9 9
Burn(s) 9 9
Injury 8 8
Cancer 8 8
Balance Problems 8 8
Partial Hearing Loss 7 7
Convulsion/Seizure 7 7
Skin Disorders 7 7
Unspecified Tissue Injury 7 7
Missing Value Reason 7 7
Foreign Body In Patient 7 7
Twitching 7 7
Perforation 7 7
Nerve Damage 7 7
Device Overstimulation of Tissue 7 7
Complaint, Ill-Defined 6 6
Solid Tumour 6 6
Unspecified Ear or Labyrinth Problem 6 6
Blister 5 5
Eczema 5 5
Fungal Infection 5 5
Pressure Sores 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Bionics, LLC III Nov-25-2020
2 Advanced Bionics, LLC II May-15-2020
3 Advanced Bionics, LLC III Mar-04-2020
4 Advanced Bionics, LLC III Feb-18-2020
5 Advanced Bionics, LLC II Apr-03-2019
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