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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)
2018 2019 2020 2021 2022 2023
20 35 25 20 24 15

MDR Year MDR Reports MDR Events
2018 3054 3054
2019 3406 3406
2020 4403 4403
2021 5260 5260
2022 5500 5500
2023 4830 4830

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 6248 6248
Output Problem 4699 4699
Mechanical Problem 4202 4202
Adverse Event Without Identified Device or Use Problem 3864 3864
Impedance Problem 3826 3826
Migration 1396 1396
Insufficient Information 1348 1348
Expulsion 1336 1336
Therapeutic or Diagnostic Output Failure 942 942
Circuit Failure 663 663
No Device Output 604 604
Device Operates Differently Than Expected 549 549
Device Dislodged or Dislocated 503 503
Migration or Expulsion of Device 449 449
Device Appears to Trigger Rejection 311 311
Positioning Failure 309 309
Material Protrusion/Extrusion 303 303
Unexpected Therapeutic Results 248 248
Output below Specifications 232 232
Intermittent Communication Failure 229 229
Fluid/Blood Leak 200 200
Patient Device Interaction Problem 162 162
Electrical /Electronic Property Problem 126 126
No Apparent Adverse Event 121 121
Malposition of Device 114 114
Patient-Device Incompatibility 106 106
Extrusion 97 97
Loose or Intermittent Connection 94 94
Positioning Problem 85 85
Electrical Shorting 74 74
Electro-Static Discharge 74 74
Melted 63 63
Battery Problem 63 63
Communication or Transmission Problem 59 59
High impedance 52 52
Device Handling Problem 51 51
Connection Problem 49 49
Noise, Audible 48 48
Failure to Read Input Signal 44 44
Inadequacy of Device Shape and/or Size 43 43
No Audible Prompt/Feedback 40 40
Device Slipped 39 39
Improper or Incorrect Procedure or Method 37 37
Product Quality Problem 33 33
Operating System Version or Upgrade Problem 31 31
Overheating of Device 30 30
Defective Device 29 29
Application Program Version or Upgrade Problem 26 26
Use of Device Problem 24 24
Difficult to Insert 23 23
Misconnection 23 23
Microbial Contamination of Device 22 22
Incorrect, Inadequate or Imprecise Result or Readings 22 22
Sparking 22 22
Break 21 21
Thermal Decomposition of Device 20 20
Unintended Movement 20 20
Leak/Splash 18 18
Device Stops Intermittently 17 17
Folded 16 16
Lack of Effect 16 16
Application Program Problem 15 15
Device Inoperable 14 14
Low impedance 13 13
Detachment of Device or Device Component 13 13
Intermittent Loss of Power 13 13
Defective Component 12 12
Failure to Deliver Shock/Stimulation 12 12
Structural Problem 11 11
Biocompatibility 11 11
Intermittent Continuity 10 10
Unintended Electrical Shock 10 10
Loosening of Implant Not Related to Bone-Ingrowth 9 9
Inaudible or Unclear Audible Prompt/Feedback 9 9
Material Deformation 9 9
Fitting Problem 8 8
Crack 8 8
Signal Artifact/Noise 7 7
Intermittent Shock/Stimulation 7 7
Programming Issue 7 7
Protective Measures Problem 6 6
Device Unsafe to Use in Environment 6 6
Increased Sensitivity 6 6
Device Tipped Over 6 6
Energy Output Problem 6 6
Fracture 6 6
Audible Prompt/Feedback Problem 6 6
Physical Resistance/Sticking 5 5
Fire 5 5
Burst Container or Vessel 5 5
Contamination 5 5
Electromagnetic Interference 5 5
Loss of Osseointegration 5 5
Device-Device Incompatibility 5 5
Device Operational Issue 5 5
Material Twisted/Bent 4 4
Failure of Device to Self-Test 4 4
Disconnection 4 4
Corroded 4 4
Computer Software Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 6875 6875
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6122 6122
Insufficient Information 2815 2815
Unspecified Infection 2375 2375
No Clinical Signs, Symptoms or Conditions 1832 1832
Hearing Impairment 1626 1626
Pain 1522 1522
No Code Available 1400 1400
Tissue Breakdown 754 754
No Known Impact Or Consequence To Patient 750 750
Head Injury 605 605
Therapeutic Response, Decreased 563 563
No Information 506 506
Bacterial Infection 425 425
Patient Problem/Medical Problem 415 415
Skin Infection 349 349
Undesired Nerve Stimulation 349 349
Swelling/ Edema 336 336
Wound Dehiscence 330 330
Implant Pain 231 231
Dizziness 230 230
Headache 214 214
Discomfort 213 213
Swelling 195 195
Necrosis 180 180
Skin Inflammation/ Irritation 164 164
Inflammation 158 158
Post Operative Wound Infection 157 157
Tinnitus 154 154
Meningitis 126 126
Purulent Discharge 104 104
Vertigo 94 94
Erythema 88 88
Hematoma 86 86
Fluid Discharge 86 86
Abscess 83 83
Therapeutic Effects, Unexpected 82 82
Skin Tears 65 65
Skin Erosion 63 63
Cerebrospinal Fluid Leakage 60 60
Tissue Damage 56 56
Impaired Healing 52 52
Ulcer 52 52
Drug Resistant Bacterial Infection 51 51
Ossification 50 50
Erosion 45 45
Fall 38 38
Hearing Loss 38 38
No Consequences Or Impact To Patient 37 37
Necrosis Of Flap Tissue 35 35
Granuloma 34 34
Cellulitis 33 33
Deafness 32 32
Discharge 32 32
Skin Irritation 32 32
Edema 31 31
Burning Sensation 30 30
Staphylococcus Aureus 29 29
Fistula 23 23
Seroma 23 23
Inadequate Pain Relief 22 22
Electric Shock 21 21
Nausea 20 20
No Patient Involvement 18 18
Hemorrhage/Bleeding 17 17
Irritation 17 17
Cyst(s) 17 17
Facial Nerve Paralysis 16 16
Hypersensitivity/Allergic reaction 15 15
Fever 13 13
Scar Tissue 11 11
Paralysis 11 11
Itching Sensation 11 11
Vomiting 11 11
Injury 10 10
Post Traumatic Wound Infection 10 10
Fibrosis 10 10
Total Hearing Loss 9 9
Skin Burning Sensation 9 9
Complaint, Ill-Defined 9 9
Host-Tissue Reaction 9 9
Burn(s) 8 8
Perforation 8 8
Missing Value Reason 8 8
Cancer 8 8
Balance Problems 8 8
Skin Inflammation 7 7
Convulsion/Seizure 7 7
Partial Hearing Loss 7 7
Skin Disorders 7 7
Unspecified Tissue Injury 7 7
Nerve Damage 7 7
Pressure Sores 7 7
Foreign Body In Patient 7 7
Shock 7 7
Device Overstimulation of Tissue 7 7
Twitching 6 6
Numbness 6 6
Solid Tumour 6 6
Unspecified Ear or Labyrinth Problem 6 6

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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