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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 19

MDR Year MDR Reports MDR Events
2015 3102 3102
2016 2783 2783
2017 3122 3122
2018 3052 3052
2019 3407 3407
2020 3077 3077

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 5444 5444
Device Operates Differently Than Expected 3297 3297
Output Problem 2264 2264
Adverse Event Without Identified Device or Use Problem 1530 1530
Receiver Stimulator Unit 1255 1255
No Device Output 1220 1220
Insufficient Information 1083 1083
Migration or Expulsion of Device 745 745
Electrode 731 731
Migration 510 510
Extrusion 475 475
Magnet 451 451
Therapeutic or Diagnostic Output Failure 445 445
Device Stops Intermittently 282 282
Expulsion 277 277
Device Dislodged or Dislocated 233 233
Lock 200 200
Circuit Failure 191 191
Impedance Problem 161 161
Material Protrusion/Extrusion 141 141
Device Inoperable 125 125
Fluid Leak 119 119
Device Slipped 116 116
Output below Specifications 92 92
High impedance 85 85
Patient-Device Incompatibility 78 78
Break 77 77
Product Quality Problem 74 74
Malposition of Device 72 72
Positioning Problem 66 66
Battery Problem 64 64
Leak/Splash 64 64
Electrical Lead/Wire 56 56
Device Appears to Trigger Rejection 54 54
Improper or Incorrect Procedure or Method 52 52
Operating System Version or Upgrade Problem 52 52
Noise, Audible 51 51
Programming Issue 42 42
Mechanical Problem 40 40
Lithium Iodide Battery 39 39
Communication or Transmission Problem 39 39
Housing 36 36
Folded 34 34
Loose or Intermittent Connection 32 32
Unexpected Therapeutic Results 31 31
Difficult to Insert 26 26
Defective Device 26 26
Unintended Movement 22 22
Patient Device Interaction Problem 22 22
Use of Device Problem 19 19
Application Program Version or Upgrade Problem 19 19
No Audible Prompt/Feedback 18 18
Electrical Shorting 17 17
Connection Problem 15 15
Device Operational Issue 14 14
Defective Component 14 14
Locking Mechanism 14 14
Intermittent Loss of Power 13 13
Device Handling Problem 13 13
Improper Device Output 13 13
Tip 12 12
Contamination 11 11
Electrical /Electronic Property Problem 11 11
Battery 11 11
Electromagnetic Interference 10 10
Intermittent Continuity 10 10
Application Program Problem 10 10
Fitting Problem 10 10
Device Issue 10 10
Inaudible or Unclear Audible Prompt/Feedback 9 9
Melted 9 9
Inappropriate/Inadequate Shock/Stimulation 9 9
Missing Value Reason 9 9
Incorrect, Inadequate or Imprecise Resultor Readings 8 8
Microbial Contamination of Device 8 8
Device Displays Incorrect Message 8 8
Biocompatibility 8 8
Human-Device Interface Problem 7 7
Unintended Collision 7 7
Mechanics Altered 7 7
Protective Measures Problem 6 6
Overheating of Device 6 6
Nonstandard Device 6 6
Degraded 6 6
Material Deformation 6 6
Chemical Spillage 6 6
Electro-Static Discharge 6 6
Component Missing 5 5
Structural Problem 5 5
Crack 5 5
Thermal Decomposition of Device 5 5
Burst Container or Vessel 5 5
Power Problem 5 5
Physical Resistance/Sticking 4 4
Disconnection 4 4
Wire 4 4
No Audible Alarm 4 4
Premature Discharge of Battery 4 4
Bent 4 4
Fire 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 4495 4495
No Code Available 2830 2830
Hearing Impairment 2660 2660
No Known Impact Or Consequence To Patient 1496 1496
Unspecified Infection 1319 1319
Pain 1252 1252
No Information 1031 1031
Patient Problem/Medical Problem 668 668
Bacterial Infection 666 666
Deafness 543 543
Therapeutic Response, Decreased 422 422
Head Injury 405 405
Swelling 361 361
Undesired Nerve Stimulation 300 300
Hearing Loss 299 299
Headache 200 200
Dizziness 172 172
Tissue Breakdown 156 156
Discomfort 135 135
Inflammation 124 124
Meningitis 119 119
Therapeutic Effects, Unexpected 110 110
Necrosis Of Flap Tissue 100 100
No Consequences Or Impact To Patient 98 98
Wound Dehiscence 93 93
Tinnitus 90 90
Vertigo 86 86
Tissue Damage 83 83
Post Operative Wound Infection 79 79
Injury 66 66
Skin Irritation 61 61
Hematoma 61 61
Edema 59 59
Abscess 59 59
Cerebrospinal Fluid Leakage 55 55
Purulent Discharge 55 55
Erythema 54 54
Fall 49 49
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 49 49
Staphylococcus Aureus 47 47
Erosion 45 45
Impaired Healing 44 44
Discharge 41 41
Necrosis 41 41
Insufficient Information 38 38
Skin Erosion 33 33
Facial Nerve Paralysis 32 32
Complaint, Ill-Defined 31 31
Fluid Discharge 26 26
Irritation 26 26
No Clinical Signs, Symptoms or Conditions 26 26
No Patient Involvement 22 22
Fistula 19 19
Granuloma 18 18
Hemorrhage/Bleeding 17 17
Inadequate Pain Relief 17 17
Seroma 17 17
Fever 15 15
Cellulitis 15 15
Ossification 14 14
Nausea 13 13
Shock 13 13
Skin Inflammation 12 12
Skin Tears 12 12
Host-Tissue Reaction 12 12
Cyst(s) 12 12
Ulcer 11 11
Electric Shock 10 10
Scar Tissue 10 10
Missing Value Reason 10 10
Hypersensitivity/Allergic reaction 9 9
Death 9 9
Burn(s) 9 9
Bruise/Contusion 8 8
Foreign Body Reaction 7 7
Itching Sensation 7 7
Pressure Sores 7 7
Burning Sensation 6 6
Reaction 6 6
Perforation 6 6
Nerve Damage 5 5
Device Overstimulation of Tissue 5 5
Seizures 5 5
Increased Sensitivity 5 5
Numbness 5 5
Fibrosis 5 5
Twitching 5 5
Skin Discoloration 5 5
Vomiting 4 4
Electrolyte Imbalance 4 4
Sepsis 4 4
Idioventricular Rhythm 4 4
Skin Infection 4 4
Implant Pain 3 3
Swelling/ Edema 3 3
Balance Problems 3 3
Incompetent Cervix 3 3
Scarring 3 3
Neuropathy 3 3
Emotional Changes 3 3

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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