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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)
2021 2022 2023 2024 2025 2026
20 24 18 17 17 6

MDR Year MDR Reports MDR Events
2021 5260 5277
2022 5502 5536
2023 5727 5757
2024 5602 5615
2025 5511 5511
2026 2572 2572

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 6495 6496
Appropriate Device Problem Term/Code Not Available 5573 5627
Adverse Event Without Identified Device or Use Problem 4675 4685
Impedance Problem 2492 2492
Expulsion 2274 2296
Output Problem 2140 2141
Migration 1903 1903
Circuit Failure 1208 1208
Insufficient Device Problem Information 1186 1194
Positioning Failure 678 680
Therapeutic or Diagnostic Output Failure 634 634
Device Dislodged or Dislocated 509 509
Device Appears to Trigger Rejection 503 505
Unexpected Therapeutic Results 455 455
Intermittent Communication Failure 445 445
No Device Output 321 321
Failure to Deliver Shock/Stimulation 271 271
No Apparent Adverse Event 232 233
Failure to Read Input Signal 196 196
Electrical Shorting 192 192
Loose or Intermittent Connection 185 185
Patient Device Interaction Problem 182 185
Fluid/Blood Leak 177 177
Electrical /Electronic Property Problem 176 176
Inadequacy of Device Shape and/or Size 143 144
Malposition of Device 137 137
Signal Artifact/Noise 111 111
Device Handling Problem 101 101
Electrostatic Discharge 96 96
Overheating of Device 94 94
High impedance 83 83
Melted 82 82
Migration or Expulsion of Device 80 80
Patient-Device Incompatibility 74 74
Lack of Effect 66 66
Battery Problem 62 62
Microbial Contamination of Device 58 58
Intermittent Shock/Stimulation 57 57
Positioning Problem 42 42
Defibrillation/Stimulation Problem 38 38
Noise, Audible 37 37
Sparking 34 34
Communication or Transmission Problem 33 33
Increased Sensitivity 30 30
Improper or Incorrect Procedure or Method 30 30
Fire 23 23
Connection Problem 22 22
Therapy Delivered to Incorrect Body Area 19 19
Crack 19 19
Device Emits Odor 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 11979 11994
Failure of Implant 6468 6469
No Clinical Signs, Symptoms or Conditions 3888 3898
Insufficient Information 3153 3163
Unspecified Infection 2836 2870
Pain 1652 1658
Tissue Breakdown 1495 1521
Head Injury 896 897
Swelling/ Edema 676 679
Medical device site infection 522 522
Wound Dehiscence 505 518
Implant Pain 494 497
Skin Infection 457 465
Dizziness 403 404
Bacterial Infection 388 388
Undesired Nerve Stimulation 371 371
Discomfort 342 345
Necrosis 316 321
Skin Inflammation/ Irritation 292 293
Headache 289 290
Tinnitus 245 245
Fluid Discharge 211 211
Post Operative Wound Infection 203 205
Hearing Impairment 198 198
Purulent Discharge 176 176
Inflammation 173 173
Skin Tears 166 166
Vertigo 163 163
Meningitis 157 157
Abscess 143 146
Infectious Otitis Media 127 127
Erythema 125 125
Impaired Healing 122 123
Skin Erosion 112 112
Drug Resistant Bacterial Infection 104 105
Fall 94 94
Hematoma 91 92
Cerebrospinal Fluid Leakage 83 83
Ulcer 60 60
Mastoiditis 60 60
Extraskeletal ossification 55 55
Seroma 52 52
Cyst(s) 50 50
Electric Shock 49 49
Therapeutic Response, Decreased 48 48
Wound Infection 46 46
Erosion 46 47
Burning Sensation 45 45
Cellulitis 43 43
Fistula 41 41

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Bionics, LLC II Jun-01-2026
2 Advanced Bionics, LLC II Apr-27-2026
3 Advanced Bionics, LLC II Mar-05-2026
4 Advanced Bionics, LLC II May-22-2025
5 MED-EL Elektromedizinische Gereate, Gmbh II Jul-12-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
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