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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 19

MDR Year MDR Reports MDR Events
2016 2783 2783
2017 3122 3122
2018 3052 3052
2019 3407 3407
2020 4403 4403
2021 4231 4231

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 5606 5606
Output Problem 3336 3336
Device Operates Differently Than Expected 2619 2619
Adverse Event Without Identified Device or Use Problem 2331 2331
Insufficient Information 1162 1162
Impedance Problem 1124 1124
Mechanical Problem 1001 1001
No Device Output 925 925
Therapeutic or Diagnostic Output Failure 827 827
Migration 781 781
Migration or Expulsion of Device 663 663
Expulsion 539 539
Extrusion 419 419
Device Dislodged or Dislocated 350 350
Circuit Failure 277 277
Material Protrusion/Extrusion 226 226
Output below Specifications 192 192
Device Appears to Trigger Rejection 178 178
Device Stops Intermittently 160 160
Fluid Leak 156 156
Patient-Device Incompatibility 106 106
Device Slipped 100 100
Patient Device Interaction Problem 97 97
Malposition of Device 82 82
Positioning Problem 78 78
Device Inoperable 71 71
Positioning Failure 69 69
Product Quality Problem 67 67
Unexpected Therapeutic Results 57 57
Operating System Version or Upgrade Problem 56 56
High impedance 50 50
Battery Problem 49 49
Improper or Incorrect Procedure or Method 48 48
Intermittent Communication Failure 48 48
Loose or Intermittent Connection 47 47
Electrical /Electronic Property Problem 45 45
Communication or Transmission Problem 38 38
Programming Issue 35 35
No Audible Prompt/Feedback 35 35
Noise, Audible 33 33
Electrical Shorting 31 31
Folded 30 30
Defective Device 28 28
Application Program Version or Upgrade Problem 26 26
Unintended Movement 26 26
Melted 24 24
Break 23 23
Electro-Static Discharge 23 23
Difficult to Insert 22 22
No Apparent Adverse Event 22 22
Incorrect, Inadequate or Imprecise Resultor Readings 21 21
Use of Device Problem 20 20
Connection Problem 19 19
Thermal Decomposition of Device 16 16
Device Handling Problem 16 16
Overheating of Device 15 15
Defective Component 14 14
Device Operational Issue 13 13
Intermittent Loss of Power 13 13
Low impedance 12 12
Inaudible or Unclear Audible Prompt/Feedback 11 11
Contamination 11 11
Intermittent Continuity 10 10
Leak/Splash 10 10
Biocompatibility 10 10
Application Program Problem 10 10
Structural Problem 10 10
Microbial Contamination of Device 9 9
Device Issue 9 9
Electromagnetic Interference 9 9
Fitting Problem 8 8
Sparking 8 8
Missing Value Reason 8 8
Inappropriate/Inadequate Shock/Stimulation 7 7
Crack 6 6
Fire 6 6
Device Tipped Over 6 6
Device Unsafe to Use in Environment 6 6
Protective Measures Problem 6 6
Material Deformation 6 6
Mechanics Altered 5 5
Detachment of Device or Device Component 5 5
Burst Container or Vessel 5 5
Premature Discharge of Battery 5 5
Physical Resistance/Sticking 5 5
Audible Prompt/Feedback Problem 5 5
Unintended Electrical Shock 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
No Audible Alarm 4 4
Computer Software Problem 4 4
Computer Operating System Problem 4 4
Component Missing 4 4
Power Problem 4 4
Device-Device Incompatibility 4 4
Electromagnetic Compatibility Problem 3 3
Failure of Device to Self-Test 3 3
Improper Device Output 3 3
Contamination /Decontamination Problem 3 3
Disconnection 3 3
Difficult to Remove 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 5445 5445
No Code Available 2386 2386
Hearing Impairment 2317 2317
Unspecified Infection 1668 1668
Pain 1307 1307
No Known Impact Or Consequence To Patient 1235 1235
Insufficient Information 1198 1198
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 820 820
No Information 773 773
Patient Problem/Medical Problem 653 653
No Clinical Signs, Symptoms or Conditions 631 631
Therapeutic Response, Decreased 572 572
Bacterial Infection 567 567
Head Injury 479 479
Undesired Nerve Stimulation 324 324
Swelling 317 317
Tissue Breakdown 292 292
Deafness 221 221
Headache 199 199
Dizziness 184 184
Inflammation 154 154
Wound Dehiscence 149 149
Discomfort 144 144
Swelling/ Edema 133 133
Post Operative Wound Infection 127 127
Tinnitus 126 126
Implant Pain 123 123
Meningitis 122 122
Skin Infection 110 110
Therapeutic Effects, Unexpected 90 90
Hearing Loss 87 87
Vertigo 86 86
Necrosis Of Flap Tissue 83 83
Hematoma 77 77
Purulent Discharge 77 77
Tissue Damage 76 76
No Consequences Or Impact To Patient 75 75
Necrosis 74 74
Abscess 65 65
Erythema 57 57
Skin Irritation 53 53
Skin Inflammation/ Irritation 52 52
Erosion 50 50
Edema 48 48
Staphylococcus Aureus 46 46
Fluid Discharge 46 46
Impaired Healing 45 45
Cerebrospinal Fluid Leakage 44 44
Discharge 41 41
Injury 38 38
Skin Erosion 33 33
Irritation 27 27
Skin Tears 25 25
Facial Nerve Paralysis 24 24
Fistula 23 23
Granuloma 23 23
Ossification 23 23
Ulcer 22 22
Inadequate Pain Relief 21 21
No Patient Involvement 20 20
Fall 19 19
Cellulitis 18 18
Seroma 18 18
Burning Sensation 16 16
Complaint, Ill-Defined 15 15
Hemorrhage/Bleeding 15 15
Fever 13 13
Cyst(s) 13 13
Nausea 13 13
Electric Shock 13 13
Hypersensitivity/Allergic reaction 12 12
Itching Sensation 11 11
Host-Tissue Reaction 11 11
Skin Inflammation 11 11
Scar Tissue 10 10
Missing Value Reason 10 10
Burn(s) 9 9
Foreign Body Reaction 7 7
Death 7 7
Drug Resistant Bacterial Infection 7 7
Partial Hearing Loss 6 6
Bruise/Contusion 6 6
Perforation 6 6
Fibrosis 6 6
Foreign Body In Patient 6 6
Numbness 6 6
Post Traumatic Wound Infection 6 6
Pressure Sores 6 6
Vomiting 6 6
Twitching 6 6
Reaction 5 5
Paralysis 5 5
Shock 5 5
Skin Discoloration 5 5
Increased Sensitivity 5 5
Sepsis 5 5
Nerve Damage 5 5
Balance Problems 5 5
Skin Disorders 4 4
Solid Tumour 4 4

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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