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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, infusion, implanted, programmable
Product CodeLKK
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
57 49 32 32 19 6

MDR Year MDR Reports MDR Events
2019 5652 5652
2020 5115 5115
2021 4713 4713
2022 4310 4310
2023 4042 4042
2024 1089 1089

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6903 6903
Infusion or Flow Problem 3661 3661
Insufficient Flow or Under Infusion 3456 3456
Insufficient Information 3224 3224
Migration or Expulsion of Device 2959 2959
Pumping Stopped 2662 2662
Material Integrity Problem 2261 2261
Obstruction of Flow 2085 2085
Electromagnetic Interference 1058 1058
Filling Problem 854 854
Improper or Incorrect Procedure or Method 846 846
Use of Device Problem 723 723
Fluid/Blood Leak 714 714
Excess Flow or Over-Infusion 615 615
Improper Flow or Infusion 408 408
Disconnection 307 307
Communication or Transmission Problem 296 296
Positioning Problem 291 291
Patient Device Interaction Problem 178 178
Device Alarm System 161 161
Device Ingredient or Reagent Problem 154 154
No Audible Alarm 146 146
Failure to Disconnect 137 137
Data Problem 130 130
Human-Device Interface Problem 129 129
Protective Measures Problem 102 102
Migration 101 101
Material Split, Cut or Torn 100 100
Connection Problem 87 87
Inappropriate or Unexpected Reset 81 81
Difficult to Advance 77 77
Appropriate Term/Code Not Available 76 76
Battery Problem 65 65
Failure to Interrogate 61 61
No Flow 60 60
Inadequacy of Device Shape and/or Size 52 52
Premature Elective Replacement Indicator 49 49
Application Program Problem 47 47
Ambient Temperature Problem 45 45
Misconnection 42 42
Material Twisted/Bent 40 40
Device Dislodged or Dislocated 35 35
Leak/Splash 31 31
Fracture 28 28
Mechanical Problem 28 28
Material Deformation 24 24
Excessive Heating 20 20
Vibration 19 19
Unintended Electrical Shock 18 18
Therapeutic or Diagnostic Output Failure 18 18
Retraction Problem 17 17
Particulates 15 15
Material Puncture/Hole 13 13
Output Problem 13 13
Noise, Audible 13 13
Detachment of Device or Device Component 10 10
Increase in Pressure 10 10
Component Missing 10 10
Separation Failure 9 9
Break 9 9
Defective Device 8 8
Premature End-of-Life Indicator 8 8
Activation, Positioning or Separation Problem 8 8
Unauthorized Access to Computer System 8 8
Unexpected Shutdown 8 8
No Apparent Adverse Event 7 7
Malposition of Device 7 7
Defective Component 7 7
Contamination 7 7
Difficult to Insert 7 7
Nonstandard Device 6 6
Inaccurate Delivery 6 6
Decrease in Pressure 6 6
Patient-Device Incompatibility 6 6
Component or Accessory Incompatibility 6 6
Device Markings/Labelling Problem 5 5
Unintended Movement 5 5
Difficult to Flush 5 5
Complete Blockage 5 5
Premature Discharge of Battery 4 4
Device Difficult to Setup or Prepare 4 4
Material Too Rigid or Stiff 4 4
Failure to Infuse 4 4
Microbial Contamination of Device 4 4
Failure to Deliver 4 4
Packaging Problem 4 4
Device Handling Problem 4 4
Free or Unrestricted Flow 4 4
Environmental Compatibility Problem 4 4
Contamination /Decontamination Problem 3 3
Pumping Problem 3 3
Off-Label Use 3 3
Inaccurate Flow Rate 3 3
Difficult to Interrogate 3 3
Failure to Power Up 2 2
Computer Software Problem 2 2
Material Erosion 2 2
Defective Alarm 2 2
Crack 2 2
Failure to Pump 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6356 6356
No Known Impact Or Consequence To Patient 4261 4261
Pain 3896 3896
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2165 2165
Unspecified Infection 1960 1960
Therapeutic Response, Decreased 1857 1857
Insufficient Information 1834 1834
Muscular Rigidity 1393 1393
Seroma 757 757
Complaint, Ill-Defined 749 749
Discomfort 700 700
Cerebrospinal Fluid Leakage 681 681
Therapeutic Effects, Unexpected 668 668
Nausea 499 499
Inadequate Pain Relief 476 476
Malaise 475 475
Headache 454 454
Overdose 425 425
Wound Dehiscence 416 416
Cognitive Changes 409 409
Vomiting 399 399
Pocket Erosion 384 384
Loss of consciousness 368 368
Erythema 337 337
Swelling/ Edema 332 332
Ambulation Difficulties 316 316
Fluid Discharge 313 313
Fatigue 312 312
Cramp(s) /Muscle Spasm(s) 270 270
Granuloma 245 245
Muscle Weakness 245 245
Itching Sensation 245 245
Fever 238 238
Numbness 235 235
Post Operative Wound Infection 221 221
Muscle Spasm(s) 219 219
Sleep Dysfunction 209 209
Bacterial Infection 201 201
Scar Tissue 187 187
Swelling 186 186
Shaking/Tremors 185 185
Impaired Healing 180 180
Device Embedded In Tissue or Plaque 177 177
Purulent Discharge 170 170
Burning Sensation 164 164
Dizziness 157 157
Lethargy 157 157
Diarrhea 157 157
Diaphoresis 145 145
Anxiety 143 143
Headache, Lumbar Puncture 128 128
Confusion/ Disorientation 124 124
Irritability 123 123
Chills 119 119
High Blood Pressure/ Hypertension 119 119
Sweating 114 114
Convulsion/Seizure 111 111
Patient Problem/Medical Problem 102 102
Low Blood Pressure/ Hypotension 99 99
Weight Changes 95 95
Hematoma 93 93
Meningitis 91 91
Dyspnea 88 88
Hemorrhage/Bleeding 88 88
Sepsis 88 88
Seizures 87 87
Tachycardia 85 85
Underdose 84 84
No Code Available 83 83
Twiddlers Syndrome 80 80
Fall 78 78
Inflammation 77 77
Erosion 73 73
Skin Erosion 67 67
Alteration in Body Temperature 66 66
Dysphasia 65 65
Foreign Body Reaction 64 64
Bruise/Contusion 63 63
Distress 59 59
Decreased Respiratory Rate 55 55
Abdominal Pain 55 55
Abscess 55 55
Alteration In Body Temperature 54 54
Coma 54 54
Skin Inflammation/ Irritation 51 51
Emotional Changes 49 49
Rash 48 48
Unspecified Nervous System Problem 46 46
Staphylococcus Aureus 45 45
Cellulitis 45 45
Test Result 45 45
Pressure Sores 43 43
Tingling 43 43
Bradycardia 43 43
Paralysis 43 43
Paresthesia 43 43
Apnea 41 41
Cardiac Arrest 39 39
Oversedation 39 39
Weakness 39 39

Recalls
Manufacturer Recall Class Date Posted
1 Flowonix Medical Inc II Jul-01-2021
2 Flowonix Medical Inc II Feb-10-2020
3 Flowonix Medical Inc II Jun-03-2019
4 Intera Oncology, Inc. I Aug-22-2022
5 Medtronic Inc. II Dec-09-2023
6 Medtronic Inc. II Jun-03-2020
7 Medtronic Neuromodulation II Dec-22-2023
8 Medtronic Neuromodulation I Dec-03-2019
9 Smiths Medical ASD Inc. II Sep-23-2019
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