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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)
2015 2016 2017 2018 2019 2020
23 25 31 20 35 16

MDR Year MDR Reports MDR Events
2015 3102 3102
2016 2783 2783
2017 3122 3122
2018 3052 3052
2019 3407 3407
2020 2620 2620

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 5373 5373
Device Operates Differently Than Expected 3297 3297
Output Problem 2174 2174
Adverse Event Without Identified Device or Use Problem 1449 1449
Receiver Stimulator Unit 1251 1251
No Device Output 1209 1209
Insufficient Information 1074 1074
Migration or Expulsion of Device 736 736
Electrode 728 728
Migration 489 489
Extrusion 475 475
Magnet 449 449
Therapeutic or Diagnostic Output Failure 368 368
Device Stops Intermittently 282 282
Expulsion 260 260
Device Dislodged or Dislocated 223 223
Lock 200 200
Circuit Failure 185 185
Impedance Problem 145 145
Material Protrusion/Extrusion 135 135
Device Inoperable 125 125
Fluid Leak 116 116
Device Slipped 116 116
Output below Specifications 91 91
High impedance 85 85
Patient-Device Incompatibility 77 77
Break 76 76
Product Quality Problem 74 74
Malposition of Device 69 69
Battery Problem 64 64
Leak/Splash 64 64
Positioning Problem 63 63
Electrical Lead/Wire 55 55
Operating System Version or Upgrade Problem 52 52
Device Appears to Trigger Rejection 51 51
Improper or Incorrect Procedure or Method 50 50
Noise, Audible 50 50
Programming Issue 42 42
Mechanical Problem 40 40
Communication or Transmission Problem 39 39
Lithium Iodide Battery 39 39
Housing 36 36
Folded 34 34
Loose or Intermittent Connection 32 32
Unexpected Therapeutic Results 29 29
Defective Device 26 26
Difficult to Insert 24 24
Unintended Movement 21 21
Application Program Version or Upgrade Problem 19 19
Use of Device Problem 18 18
Electrical Shorting 17 17
Connection Problem 15 15
No Audible Prompt/Feedback 15 15
Defective Component 14 14
Device Operational Issue 14 14
Locking Mechanism 14 14
Intermittent Loss of Power 13 13
Improper Device Output 13 13
Tip 12 12
Device Handling Problem 11 11
Battery 11 11
Contamination 11 11
Intermittent Continuity 10 10
Electrical /Electronic Property Problem 10 10
Fitting Problem 10 10
Application Program Problem 10 10
Device Issue 10 10
Melted 9 9
Electromagnetic Interference 9 9
Missing Value Reason 9 9
Inappropriate/Inadequate Shock/Stimulation 9 9
Inaudible or Unclear Audible Prompt/Feedback 9 9
Device Displays Incorrect Message 8 8
Patient Device Interaction Problem 8 8
Microbial Contamination of Device 8 8
Human-Device Interface Problem 7 7
Unintended Collision 7 7
Mechanics Altered 7 7
Material Deformation 6 6
Biocompatibility 6 6
Chemical Spillage 6 6
Protective Measures Problem 6 6
Nonstandard Device 6 6
Degraded 6 6
Burst Container or Vessel 5 5
Crack 5 5
Component Missing 5 5
Structural Problem 5 5
Electro-Static Discharge 5 5
Power Problem 5 5
Physical Resistance/Sticking 4 4
Device Unsafe to Use in Environment 4 4
Disconnection 4 4
Premature Discharge of Battery 4 4
Wire 4 4
Computer Operating System Problem 4 4
Failure to Sense 4 4
Overheating of Device 4 4
No Audible Alarm 4 4
Bent 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 4416 4416
No Code Available 2810 2810
Hearing Impairment 2640 2640
No Known Impact Or Consequence To Patient 1480 1480
Unspecified Infection 1286 1286
Pain 1237 1237
No Information 1025 1025
Patient Problem/Medical Problem 665 665
Bacterial Infection 661 661
Deafness 543 543
Head Injury 378 378
Swelling 359 359
Therapeutic Response, Decreased 325 325
Hearing Loss 299 299
Undesired Nerve Stimulation 294 294
Headache 199 199
Dizziness 171 171
Tissue Breakdown 153 153
Discomfort 130 130
Inflammation 123 123
Meningitis 116 116
Therapeutic Effects, Unexpected 102 102
Necrosis Of Flap Tissue 99 99
No Consequences Or Impact To Patient 96 96
Wound Dehiscence 88 88
Tinnitus 87 87
Vertigo 86 86
Tissue Damage 83 83
Post Operative Wound Infection 73 73
Injury 66 66
Skin Irritation 60 60
Abscess 59 59
Hematoma 59 59
Edema 59 59
Purulent Discharge 55 55
Erythema 54 54
Cerebrospinal Fluid Leakage 54 54
Fall 47 47
Staphylococcus Aureus 47 47
Erosion 45 45
Impaired Healing 44 44
Discharge 41 41
Necrosis 38 38
Skin Erosion 33 33
Facial Nerve Paralysis 31 31
Complaint, Ill-Defined 31 31
Fluid Discharge 26 26
Irritation 26 26
No Patient Involvement 22 22
Fistula 19 19
Hemorrhage/Bleeding 17 17
Inadequate Pain Relief 17 17
Seroma 17 17
Granuloma 16 16
Fever 15 15
Ossification 14 14
Cellulitis 13 13
Nausea 13 13
Shock 13 13
Cyst(s) 12 12
Host-Tissue Reaction 12 12
Skin Inflammation 12 12
Electric Shock 10 10
Scar Tissue 10 10
Missing Value Reason 10 10
Death 9 9
Ulcer 9 9
Skin Tears 9 9
Burn(s) 9 9
Hypersensitivity/Allergic reaction 9 9
Bruise/Contusion 8 8
Foreign Body Reaction 7 7
Itching Sensation 7 7
Pressure Sores 7 7
Perforation 6 6
Reaction 6 6
Seizures 5 5
Burning Sensation 5 5
Twitching 5 5
Nerve Damage 5 5
Fibrosis 5 5
Skin Discoloration 5 5
Increased Sensitivity 5 5
Numbness 5 5
Sepsis 4 4
Idioventricular Rhythm 4 4
Device Overstimulation of Tissue 4 4
Vomiting 4 4
Electrolyte Imbalance 4 4
Blood Loss 3 3
Therapeutic Response, Increased 3 3
Scarring 3 3
Incompetent Cervix 3 3
Paresis 3 3
Neuropathy 3 3
Emotional Changes 3 3
Sweating 3 3
Organ Dehiscence 3 3
Ulceration 3 3
Neck Pain 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Bionics, LLC II May-15-2020
2 Advanced Bionics, LLC III Mar-04-2020
3 Advanced Bionics, LLC III Feb-18-2020
4 Advanced Bionics, LLC II Apr-03-2019
5 Cochlear Americas Inc. II Jul-20-2015
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