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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)
2016 2017 2018 2019 2020 2021
25 31 20 35 25 9

MDR Year MDR Reports MDR Events
2016 2783 2783
2017 3122 3122
2018 3052 3052
2019 3407 3407
2020 4403 4403
2021 2395 2395

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 5185 5185
Output Problem 2956 2956
Device Operates Differently Than Expected 2619 2619
Adverse Event Without Identified Device or Use Problem 2041 2041
Insufficient Information 1022 1022
No Device Output 903 903
Impedance Problem 720 720
Therapeutic or Diagnostic Output Failure 713 713
Migration 672 672
Migration or Expulsion of Device 644 644
Mechanical Problem 541 541
Expulsion 475 475
Extrusion 419 419
Device Dislodged or Dislocated 315 315
Circuit Failure 248 248
Material Protrusion/Extrusion 193 193
Output below Specifications 179 179
Device Stops Intermittently 160 160
Fluid Leak 142 142
Device Slipped 100 100
Patient-Device Incompatibility 100 100
Device Appears to Trigger Rejection 92 92
Patient Device Interaction Problem 89 89
Malposition of Device 75 75
Positioning Problem 73 73
Device Inoperable 71 71
Product Quality Problem 66 66
Operating System Version or Upgrade Problem 54 54
Battery Problem 47 47
Improper or Incorrect Procedure or Method 47 47
High impedance 45 45
Loose or Intermittent Connection 41 41
Positioning Failure 38 38
Communication or Transmission Problem 38 38
Unexpected Therapeutic Results 37 37
Programming Issue 35 35
Noise, Audible 31 31
Folded 30 30
Electrical /Electronic Property Problem 28 28
Defective Device 26 26
Unintended Movement 26 26
Break 23 23
Intermittent Communication Failure 22 22
Application Program Version or Upgrade Problem 21 21
Incorrect, Inadequate or Imprecise Resultor Readings 20 20
Use of Device Problem 20 20
No Audible Prompt/Feedback 20 20
Difficult to Insert 19 19
Melted 18 18
Electrical Shorting 17 17
No Apparent Adverse Event 16 16
Thermal Decomposition of Device 16 16
Device Handling Problem 15 15
Defective Component 14 14
Overheating of Device 13 13
Device Operational Issue 13 13
Intermittent Loss of Power 13 13
Connection Problem 12 12
Low impedance 12 12
Inaudible or Unclear Audible Prompt/Feedback 11 11
Contamination 11 11
Intermittent Continuity 10 10
Leak/Splash 10 10
Electro-Static Discharge 10 10
Application Program Problem 10 10
Microbial Contamination of Device 9 9
Structural Problem 9 9
Device Issue 9 9
Electromagnetic Interference 9 9
Fitting Problem 8 8
Sparking 8 8
Biocompatibility 8 8
Missing Value Reason 8 8
Protective Measures Problem 6 6
Material Deformation 6 6
Device Tipped Over 6 6
Device Unsafe to Use in Environment 6 6
Inappropriate/Inadequate Shock/Stimulation 6 6
Burst Container or Vessel 5 5
Premature Discharge of Battery 5 5
Mechanics Altered 5 5
Audible Prompt/Feedback Problem 5 5
Physical Resistance/Sticking 5 5
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Unintended Electrical Shock 4 4
Power Problem 4 4
Computer Operating System Problem 4 4
Component Missing 4 4
Crack 4 4
No Audible Alarm 4 4
Fire 4 4
Disconnection 3 3
Computer Software Problem 3 3
Difficult to Remove 3 3
Contamination /Decontamination Problem 3 3
Device-Device Incompatibility 3 3
Improper Device Output 3 3
Electromagnetic Compatibility Problem 3 3
Program or Algorithm Execution Problem 3 3
Electronic Property Issue 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 4980 4980
No Code Available 2386 2386
Hearing Impairment 2288 2288
Unspecified Infection 1513 1513
Pain 1235 1235
No Known Impact Or Consequence To Patient 1235 1235
No Information 773 773
Insufficient Information 693 693
Patient Problem/Medical Problem 653 653
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 578 578
Therapeutic Response, Decreased 572 572
Bacterial Infection 543 543
Head Injury 452 452
No Clinical Signs, Symptoms or Conditions 406 406
Swelling 317 317
Undesired Nerve Stimulation 304 304
Deafness 221 221
Tissue Breakdown 204 204
Headache 183 183
Dizziness 168 168
Inflammation 151 151
Discomfort 137 137
Wound Dehiscence 125 125
Meningitis 120 120
Post Operative Wound Infection 107 107
Tinnitus 107 107
Therapeutic Effects, Unexpected 90 90
Hearing Loss 87 87
Necrosis Of Flap Tissue 83 83
Vertigo 80 80
Tissue Damage 76 76
Swelling/ Edema 76 76
Implant Pain 75 75
No Consequences Or Impact To Patient 75 75
Hematoma 69 69
Purulent Discharge 68 68
Necrosis 63 63
Abscess 60 60
Erythema 55 55
Skin Irritation 53 53
Skin Infection 51 51
Edema 48 48
Erosion 46 46
Staphylococcus Aureus 46 46
Discharge 41 41
Impaired Healing 41 41
Injury 38 38
Cerebrospinal Fluid Leakage 38 38
Fluid Discharge 35 35
Skin Erosion 33 33
Skin Inflammation/ Irritation 28 28
Irritation 27 27
Facial Nerve Paralysis 24 24
Fistula 21 21
Inadequate Pain Relief 21 21
Skin Tears 21 21
No Patient Involvement 20 20
Granuloma 20 20
Ossification 19 19
Seroma 17 17
Ulcer 17 17
Complaint, Ill-Defined 15 15
Cellulitis 15 15
Fall 15 15
Hemorrhage/Bleeding 13 13
Cyst(s) 13 13
Nausea 13 13
Electric Shock 13 13
Skin Inflammation 11 11
Burning Sensation 11 11
Host-Tissue Reaction 11 11
Fever 11 11
Hypersensitivity/Allergic reaction 10 10
Missing Value Reason 10 10
Itching Sensation 9 9
Scar Tissue 9 9
Burn(s) 7 7
Foreign Body Reaction 7 7
Death 7 7
Perforation 6 6
Twitching 6 6
Pressure Sores 6 6
Vomiting 6 6
Fibrosis 6 6
Numbness 6 6
Reaction 5 5
Foreign Body In Patient 5 5
Shock 5 5
Skin Discoloration 5 5
Increased Sensitivity 5 5
Sepsis 5 5
Bruise/Contusion 5 5
Partial Hearing Loss 5 5
Balance Problems 4 4
Skin Disorders 4 4
Abrasion 4 4
Nerve Damage 4 4
Post Traumatic Wound Infection 4 4
Device Overstimulation of Tissue 4 4
Blurred Vision 3 3

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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