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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)
2018 2019 2020 2021 2022 2023
55 57 49 32 32 2

MDR Year MDR Reports MDR Events
2018 6936 6936
2019 5652 5652
2020 5115 5115
2021 4713 4713
2022 4311 4311
2023 709 709

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7418 7418
Insufficient Flow or Under Infusion 3757 3757
Infusion or Flow Problem 3349 3349
Pumping Stopped 3314 3314
Insufficient Information 3174 3174
Migration or Expulsion of Device 2829 2829
Material Integrity Problem 2354 2354
Obstruction of Flow 1950 1950
Electromagnetic Interference 1017 1017
Use of Device Problem 990 990
Improper or Incorrect Procedure or Method 960 960
Filling Problem 910 910
Fluid/Blood Leak 761 761
Device Operates Differently Than Expected 672 672
Excess Flow or Over-Infusion 670 670
Device Displays Incorrect Message 474 474
Improper Flow or Infusion 365 365
Disconnection 336 336
Volume Accuracy Problem 310 310
Aspiration Issue 308 308
Positioning Problem 292 292
Communication or Transmission Problem 284 284
Intermittent Infusion 222 222
Unstable 220 220
Failure To Service 212 212
No Audible Alarm 194 194
Human-Device Interface Problem 182 182
Patient Device Interaction Problem 171 171
Device Alarm System 164 164
Device Ingredient or Reagent Problem 160 160
Appropriate Term/Code Not Available 160 160
Failure to Disconnect 157 157
Data Problem 134 134
Inappropriate or Unexpected Reset 130 130
Battery Problem 110 110
Protective Measures Problem 108 108
Connection Problem 101 101
Kinked 100 100
Occlusion Within Device 100 100
Material Split, Cut or Torn 97 97
Migration 95 95
Premature Elective Replacement Indicator 79 79
Difficult to Advance 73 73
Failure to Interrogate 64 64
Nonstandard Device 58 58
Device Or Device Fragments Location Unknown 57 57
Inadequacy of Device Shape and/or Size 55 55
Mechanical Problem 54 54
No Flow 54 54
Application Program Problem 53 53
Material Twisted/Bent 46 46
Misconnection 44 44
Malposition of Device 39 39
Device Dislodged or Dislocated 39 39
Leak/Splash 38 38
Mechanical Jam 38 38
Ambient Temperature Problem 37 37
Material Deformation 33 33
Patient-Device Incompatibility 32 32
Fracture 30 30
Display or Visual Feedback Problem 28 28
Vibration 22 22
Unintended Electrical Shock 21 21
Suction Problem 19 19
Particulates 19 19
Retraction Problem 18 18
Material Puncture/Hole 17 17
Defective Device 17 17
Excessive Heating 17 17
Noise, Audible 17 17
Unintended Movement 17 17
Break 16 16
Device Issue 15 15
Increase in Pressure 14 14
Difficult to Interrogate 14 14
Detachment of Device or Device Component 13 13
Component Missing 12 12
Premature End-of-Life Indicator 12 12
Therapeutic or Diagnostic Output Failure 12 12
Pumping Problem 11 11
Decrease in Pressure 11 11
Contamination 9 9
Difficult to Insert 9 9
Failure to Deliver 9 9
Defective Component 9 9
Output Problem 9 9
Temperature Problem 9 9
Activation Failure 8 8
Mechanics Altered 8 8
Unexpected Therapeutic Results 8 8
Environmental Compatibility Problem 8 8
Inaccurate Delivery 7 7
Unauthorized Access to Computer System 7 7
Unexpected Shutdown 7 7
No Apparent Adverse Event 6 6
Missing Value Reason 6 6
Separation Failure 6 6
Component or Accessory Incompatibility 6 6
Computer Software Problem 6 6
Loss of Power 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7029 7029
Pain 4594 4596
No Clinical Signs, Symptoms or Conditions 4520 4520
Therapeutic Response, Decreased 3203 3203
Unspecified Infection 2086 2087
Muscular Rigidity 1551 1552
Insufficient Information 1392 1392
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1321 1321
Complaint, Ill-Defined 1300 1300
Therapeutic Effects, Unexpected 1172 1174
Overdose 821 821
Seroma 782 782
Discomfort 773 773
Cerebrospinal Fluid Leakage 675 675
Malaise 627 627
Nausea 596 596
Cognitive Changes 515 515
Inadequate Pain Relief 494 494
Vomiting 483 483
Headache 456 456
Wound Dehiscence 421 421
Loss of consciousness 417 417
Pocket Erosion 413 414
Ambulation Difficulties 401 401
Muscle Spasm(s) 393 393
Fatigue 383 383
Erythema 364 364
Fluid Discharge 355 355
Swelling 342 342
Itching Sensation 299 299
Granuloma 292 292
No Code Available 279 279
Fever 278 278
Muscle Weakness 267 267
Numbness 248 248
Sleep Dysfunction 246 246
Shaking/Tremors 236 236
Swelling/ Edema 228 228
Post Operative Wound Infection 212 212
Bacterial Infection 208 208
Cramp(s) /Muscle Spasm(s) 206 206
Sweating 195 195
Lethargy 194 194
Burning Sensation 186 186
Diarrhea 185 185
Scar Tissue 185 185
Underdose 184 184
Impaired Healing 183 183
Dizziness 180 180
Device Embedded In Tissue or Plaque 180 180
Purulent Discharge 178 178
Anxiety 173 173
Headache, Lumbar Puncture 165 165
Irritability 157 157
Confusion/ Disorientation 155 155
Chills 155 155
Patient Problem/Medical Problem 151 151
High Blood Pressure/ Hypertension 148 148
Seizures 144 144
Weight Changes 127 128
Low Blood Pressure/ Hypotension 120 120
Meningitis 111 111
Dyspnea 110 110
Diaphoresis 107 107
Fall 106 106
Hematoma 106 106
Alteration In Body Temperature 103 103
Sepsis 101 101
Tachycardia 96 96
Convulsion/Seizure 94 94
Inflammation 89 89
Staphylococcus Aureus 87 87
Test Result 86 86
Erosion 83 83
Abdominal Pain 82 82
Hemorrhage/Bleeding 82 82
Injury 81 81
Weakness 79 79
Dysphasia 74 74
Skin Erosion 73 73
Tingling 69 69
Decreased Respiratory Rate 68 68
Distress 67 67
Bruise/Contusion 66 66
Foreign Body Reaction 64 64
Twiddlers Syndrome 62 62
Cellulitis 61 61
Emotional Changes 60 60
Abscess 59 59
Coma 59 59
Apnea 57 57
Rash 57 57
Memory Loss/Impairment 57 57
Twiddlers Syndrome 54 54
Paralysis 51 51
Bradycardia 50 50
Twitching 49 49
Electric Shock 49 49
Death 48 48
Urinary Retention 47 47

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 Jun-03-2020
6 Medtronic Neuromodulation I Dec-03-2019
7 Medtronic Neuromodulation II Mar-03-2018
8 Medtronic Neuromodulation III Feb-06-2018
9 Smiths Medical ASD Inc. II Sep-23-2019
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