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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 1472 1472

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7010 7010
Infusion or Flow Problem 3728 3728
Insufficient Flow or Under Infusion 3495 3495
Insufficient Information 3311 3311
Migration or Expulsion of Device 3001 3001
Pumping Stopped 2689 2689
Material Integrity Problem 2302 2302
Obstruction of Flow 2119 2119
Electromagnetic Interference 1081 1081
Filling Problem 862 862
Improper or Incorrect Procedure or Method 860 860
Fluid/Blood Leak 724 724
Use of Device Problem 723 723
Excess Flow or Over-Infusion 623 623
Improper Flow or Infusion 415 415
Disconnection 311 311
Communication or Transmission Problem 307 307
Positioning Problem 303 303
Patient Device Interaction Problem 181 181
Device Alarm System 164 164
Device Ingredient or Reagent Problem 155 155
No Audible Alarm 150 150
Failure to Disconnect 139 139
Data Problem 132 132
Human-Device Interface Problem 131 131
Protective Measures Problem 104 104
Migration 101 101
Material Split, Cut or Torn 100 100
Connection Problem 93 93
Inappropriate or Unexpected Reset 83 83
Difficult to Advance 80 80
Appropriate Term/Code Not Available 77 77
Battery Problem 67 67
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 41 41
Device Dislodged or Dislocated 35 35
Leak/Splash 31 31
Fracture 28 28
Mechanical Problem 28 28
Material Deformation 25 25
Excessive Heating 22 22
Vibration 19 19
Therapeutic or Diagnostic Output Failure 18 18
Unintended Electrical Shock 18 18
Retraction Problem 17 17
Particulates 15 15
Material Puncture/Hole 13 13
Noise, Audible 13 13
Output Problem 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
Unexpected Shutdown 8 8
Unauthorized Access to Computer System 8 8
No Apparent Adverse Event 7 7
Malposition of Device 7 7
Decrease in Pressure 7 7
Defective Component 7 7
Contamination 7 7
Difficult to Insert 7 7
Nonstandard Device 6 6
Inaccurate Delivery 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
Failure to Infuse 4 4
Microbial Contamination of Device 4 4
Failure to Deliver 4 4
Device Difficult to Setup or Prepare 4 4
Material Too Rigid or Stiff 4 4
Device Handling Problem 4 4
Packaging Problem 4 4
Environmental Compatibility Problem 4 4
Free or Unrestricted Flow 4 4
Charging Problem 3 3
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6531 6531
No Known Impact Or Consequence To Patient 4261 4261
Pain 3950 3950
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2246 2246
Unspecified Infection 1988 1988
Insufficient Information 1865 1865
Therapeutic Response, Decreased 1857 1857
Muscular Rigidity 1411 1411
Seroma 765 765
Complaint, Ill-Defined 749 749
Discomfort 708 708
Cerebrospinal Fluid Leakage 695 695
Therapeutic Effects, Unexpected 668 668
Nausea 501 501
Malaise 484 484
Inadequate Pain Relief 476 476
Headache 467 467
Overdose 425 425
Wound Dehiscence 421 421
Cognitive Changes 410 410
Vomiting 403 403
Pocket Erosion 390 390
Loss of consciousness 372 372
Erythema 339 339
Swelling/ Edema 337 337
Ambulation Difficulties 321 321
Fluid Discharge 316 316
Fatigue 314 314
Cramp(s) /Muscle Spasm(s) 275 275
Muscle Weakness 251 251
Granuloma 248 248
Itching Sensation 246 246
Fever 241 241
Numbness 235 235
Post Operative Wound Infection 224 224
Muscle Spasm(s) 219 219
Sleep Dysfunction 212 212
Bacterial Infection 211 211
Scar Tissue 191 191
Shaking/Tremors 188 188
Swelling 186 186
Impaired Healing 181 181
Device Embedded In Tissue or Plaque 179 179
Purulent Discharge 172 172
Burning Sensation 167 167
Lethargy 160 160
Diarrhea 160 160
Dizziness 159 159
Diaphoresis 150 150
Anxiety 144 144
Headache, Lumbar Puncture 128 128
Irritability 125 125
Confusion/ Disorientation 124 124
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 101 101
Weight Changes 96 96
Meningitis 95 95
Hematoma 93 93
Sepsis 91 91
Hemorrhage/Bleeding 89 89
Dyspnea 89 89
Seizures 87 87
Tachycardia 86 86
Underdose 84 84
No Code Available 83 83
Twiddlers Syndrome 83 83
Inflammation 78 78
Fall 78 78
Erosion 73 73
Alteration in Body Temperature 72 72
Skin Erosion 68 68
Dysphasia 66 66
Bruise/Contusion 64 64
Foreign Body Reaction 64 64
Distress 59 59
Coma 56 56
Abdominal Pain 56 56
Abscess 56 56
Decreased Respiratory Rate 55 55
Alteration In Body Temperature 54 54
Skin Inflammation/ Irritation 51 51
Emotional Changes 50 50
Rash 48 48
Cellulitis 47 47
Unspecified Nervous System Problem 47 47
Staphylococcus Aureus 45 45
Test Result 45 45
Pressure Sores 44 44
Paralysis 44 44
Bradycardia 44 44
Paresthesia 44 44
Tingling 43 43
Apnea 42 42
Cardiac Arrest 40 40
Tissue Breakdown 40 40
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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