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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 2

MDR Year MDR Reports MDR Events
2021 5260 5277
2022 5502 5536
2023 5727 5757
2024 5602 5615
2025 5511 5511
2026 407 407

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 6280 6280
Appropriate Term/Code Not Available 5583 5637
Impedance Problem 4867 4867
Adverse Event Without Identified Device or Use Problem 4664 4674
Output Problem 2646 2647
Expulsion 2074 2096
Migration 1739 1739
Insufficient Information 1257 1265
Circuit Failure 1097 1097
Therapeutic or Diagnostic Output Failure 766 766
Positioning Failure 621 623
Device Dislodged or Dislocated 470 470
Device Appears to Trigger Rejection 441 443
Unexpected Therapeutic Results 418 418
Intermittent Communication Failure 412 412
No Device Output 296 296
No Apparent Adverse Event 214 215
Migration or Expulsion of Device 197 197
Fluid/Blood Leak 177 177
Electrical Shorting 176 176
Electrical /Electronic Property Problem 172 172
Loose or Intermittent Connection 167 167
Failure to Deliver Shock/Stimulation 166 166
Material Protrusion/Extrusion 159 160
Failure to Read Input Signal 155 155
Patient Device Interaction Problem 150 154
Malposition of Device 126 126
Inadequacy of Device Shape and/or Size 108 109
Electro-Static Discharge 89 89
Device Handling Problem 87 87
Overheating of Device 86 86
Patient-Device Incompatibility 83 84
Melted 80 80
Signal Artifact/Noise 78 78
Output below Specifications 77 77
Battery Problem 68 68
High impedance 63 63
Positioning Problem 59 59
Microbial Contamination of Device 58 58
Connection Problem 49 49
Noise, Audible 44 44
Intermittent Shock/Stimulation 38 38
Communication or Transmission Problem 33 33
Lack of Effect 33 33
Improper or Incorrect Procedure or Method 30 30
Sparking 29 29
Increased Sensitivity 27 27
No Audible Prompt/Feedback 24 24
Misconnection 23 23
Defibrillation/Stimulation Problem 20 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11405 11420
Failure of Implant 6242 6243
No Clinical Signs, Symptoms or Conditions 3344 3354
Insufficient Information 2929 2939
Unspecified Infection 2680 2714
Pain 1507 1513
Tissue Breakdown 1351 1377
Head Injury 762 763
Swelling/ Edema 580 583
Wound Dehiscence 459 472
Skin Infection 427 435
Implant Pain 403 406
Dizziness 342 343
Bacterial Infection 337 337
Undesired Nerve Stimulation 334 334
Necrosis 294 299
Discomfort 291 294
Skin Inflammation/ Irritation 261 262
Headache 256 257
Tinnitus 215 215
Hearing Impairment 196 196
Post Operative Wound Infection 178 180
Fluid Discharge 175 175
Skin Tears 145 145
Inflammation 145 145
Purulent Discharge 142 142
Meningitis 141 141
Vertigo 137 137
Abscess 131 134
Impaired Healing 104 105
Erythema 104 104
Skin Erosion 92 92
Drug Resistant Bacterial Infection 92 93
Hematoma 79 80
Cerebrospinal Fluid Leakage 74 74
Fall 73 73
Ulcer 57 57
Therapeutic Response, Decreased 48 48
Ossification 47 47
Electric Shock 45 45
Cellulitis 40 40
Seroma 39 39
Fistula 38 38
Erosion 35 36
Post Traumatic Wound Infection 35 35
Burning Sensation 34 34
Granuloma 28 31
Nausea 25 25
Hemorrhage/Bleeding 24 25
Twitching 20 20

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Bionics, LLC II May-22-2025
2 MED-EL Elektromedizinische Gereate, Gmbh II Jul-12-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
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