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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
19 21 27 21 28 23 23 25 31 20 35 25 20 24 18 3

MDR Year MDR Reports MDR Events
2014 2672 2672
2015 3104 3104
2016 2784 2784
2017 3122 3122
2018 3054 3054
2019 3406 3406
2020 4403 4403
2021 5260 5260
2022 5501 5501
2023 5730 5730
2024 1947 1949

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 10289 10289
Mechanical Problem 5171 5171
Output Problem 4918 4918
Adverse Event Without Identified Device or Use Problem 4875 4875
Impedance Problem 4210 4210
Device Operates Differently Than Expected 3606 3606
Insufficient Information 2479 2479
No Device Output 1943 1943
Migration 1589 1589
Expulsion 1578 1578
Migration or Expulsion of Device 1052 1052
Therapeutic or Diagnostic Output Failure 1004 1004
Circuit Failure 821 821
Device Dislodged or Dislocated 595 595
Extrusion 522 522
Device Stops Intermittently 411 411
Positioning Failure 382 382
Device Appears to Trigger Rejection 349 349
Material Protrusion/Extrusion 324 324
Intermittent Communication Failure 298 298
Unexpected Therapeutic Results 294 294
Break 273 273
Output below Specifications 250 250
Leak/Splash 248 248
Fluid/Blood Leak 241 241
Malposition of Device 181 181
Patient Device Interaction Problem 173 173
High impedance 169 169
Device Inoperable 165 165
Electrical /Electronic Property Problem 159 159
No Apparent Adverse Event 152 152
Positioning Problem 140 140
Patient-Device Incompatibility 140 140
Device Slipped 126 126
Battery Problem 122 122
Loose or Intermittent Connection 120 120
Noise, Audible 119 119
Electrical Shorting 110 110
Improper or Incorrect Procedure or Method 97 97
Electro-Static Discharge 90 90
Product Quality Problem 89 89
Communication or Transmission Problem 73 73
Melted 72 72
Failure to Read Input Signal 69 69
Operating System Version or Upgrade Problem 67 67
Connection Problem 66 66
Inadequacy of Device Shape and/or Size 61 61
Device Handling Problem 55 55
Programming Issue 53 53
Overheating of Device 47 47
Difficult to Insert 46 46
No Audible Prompt/Feedback 45 45
Folded 43 43
Application Program Version or Upgrade Problem 35 35
Microbial Contamination of Device 35 35
Use of Device Problem 34 34
Defective Device 32 32
Unintended Movement 31 31
Incorrect, Inadequate or Imprecise Result or Readings 25 25
Sparking 23 23
Misconnection 23 23
Improper Device Output 23 23
Thermal Decomposition of Device 22 22
Failure to Deliver Shock/Stimulation 19 19
Unintended Collision 18 18
Lack of Effect 18 18
Inappropriate/Inadequate Shock/Stimulation 17 17
Application Program Problem 16 16
Fitting Problem 15 15
Defective Component 15 15
Intermittent Continuity 15 15
Low impedance 14 14
Detachment of Device or Device Component 14 14
Device Operational Issue 14 14
Intermittent Loss of Power 13 13
Inaudible or Unclear Audible Prompt/Feedback 13 13
Contamination 12 12
Electromagnetic Interference 12 12
Biocompatibility 11 11
Structural Problem 11 11
Loosening of Implant Not Related to Bone-Ingrowth 11 11
Unintended Electrical Shock 10 10
Device Issue 10 10
Device Displays Incorrect Message 10 10
Intermittent Shock/Stimulation 10 10
Crack 10 10
Fracture 9 9
Signal Artifact/Noise 9 9
Missing Value Reason 9 9
Material Deformation 9 9
Mechanics Altered 9 9
Human-Device Interface Problem 9 9
Nonstandard Device 8 8
Degraded 7 7
Chemical Spillage 7 7
Device Tipped Over 6 6
Increased Sensitivity 6 6
Component Missing 6 6
Loss of Osseointegration 6 6
Disconnection 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 9473 9473
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7824 7824
Hearing Impairment 3335 3335
Unspecified Infection 3334 3334
No Code Available 3072 3072
Insufficient Information 2935 2935
Pain 2411 2411
No Clinical Signs, Symptoms or Conditions 2034 2036
No Known Impact Or Consequence To Patient 1773 1773
No Information 1322 1322
Bacterial Infection 1103 1103
Tissue Breakdown 971 971
Head Injury 901 901
Deafness 847 847
Therapeutic Response, Decreased 746 746
Patient Problem/Medical Problem 668 668
Hearing Loss 580 580
Undesired Nerve Stimulation 531 531
Wound Dehiscence 439 439
Swelling 435 435
Swelling/ Edema 385 385
Headache 384 384
Skin Infection 379 379
Dizziness 368 368
Discomfort 291 291
Implant Pain 243 243
Inflammation 237 237
Tinnitus 235 235
Necrosis 233 233
Meningitis 225 225
Post Operative Wound Infection 203 203
Skin Inflammation/ Irritation 177 177
Vertigo 159 159
Therapeutic Effects, Unexpected 156 156
No Consequences Or Impact To Patient 146 146
Purulent Discharge 139 139
Abscess 132 132
Hematoma 131 131
Erythema 130 130
Fluid Discharge 118 118
Necrosis Of Flap Tissue 117 117
Cerebrospinal Fluid Leakage 115 115
Fall 114 114
Impaired Healing 110 110
Injury 94 94
Tissue Damage 91 91
Erosion 85 85
Skin Tears 81 81
Skin Erosion 80 80
Complaint, Ill-Defined 70 70
Skin Irritation 68 68
Edema 67 67
Drug Resistant Bacterial Infection 64 64
Ossification 63 63
Ulcer 56 56
Staphylococcus Aureus 52 52
Discharge 48 48
Granuloma 47 47
Cellulitis 45 45
Seroma 44 44
Electric Shock 43 43
Facial Nerve Paralysis 42 42
Fistula 36 36
Burning Sensation 35 35
Hemorrhage/Bleeding 32 32
Irritation 31 31
Nausea 25 25
Hypersensitivity/Allergic reaction 25 25
Inadequate Pain Relief 25 25
Fever 24 24
Shock 23 23
No Patient Involvement 22 22
Burn(s) 20 20
Cyst(s) 19 19
Scar Tissue 19 19
Vomiting 16 16
Fibrosis 16 16
Perforation 15 15
Itching Sensation 15 15
Paralysis 13 13
Twitching 13 13
Skin Inflammation 13 13
Post Traumatic Wound Infection 12 12
Foreign Body In Patient 12 12
Pressure Sores 12 12
Host-Tissue Reaction 12 12
Bruise/Contusion 11 11
Death 11 11
Device Overstimulation of Tissue 11 11
Nerve Damage 10 10
Missing Value Reason 10 10
Cancer 10 10
Skin Burning Sensation 10 10
Partial Hearing Loss 9 9
Total Hearing Loss 9 9
Foreign Body Reaction 9 9
Numbness 9 9
Balance Problems 8 8
Convulsion/Seizure 7 7
Skin Disorders 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Bionics Corporation II Oct-22-2012
2 Advanced Bionics Corporation II Dec-21-2010
3 Advanced Bionics LLC II Sep-11-2009
4 Advanced Bionics LLC II Feb-03-2009
5 Advanced Bionics, LLC III Nov-25-2020
6 Advanced Bionics, LLC II May-15-2020
7 Advanced Bionics, LLC III Mar-04-2020
8 Advanced Bionics, LLC III Feb-18-2020
9 Advanced Bionics, LLC II Apr-03-2019
10 Cochlear Americas Inc. II Jul-20-2015
11 Cochlear Americas Inc. II Oct-03-2011
12 Cochlear Americas Inc. II Nov-02-2009
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