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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)
2017 2018 2019 2020 2021 2022
42 55 57 49 32 1

MDR Year MDR Reports MDR Events
2017 7749 7749
2018 6936 6936
2019 5652 5652
2020 5115 5115
2021 4713 4713

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7788 7788
Pumping Stopped 3753 3753
Insufficient Flow or Under Infusion 3557 3557
Insufficient Information 2534 2534
Infusion or Flow Problem 2484 2484
Material Integrity Problem 2429 2429
Migration or Expulsion of Device 2423 2423
Device Operates Differently Than Expected 2374 2374
Obstruction of Flow 1511 1511
Device Displays Incorrect Message 1408 1408
Improper or Incorrect Procedure or Method 1142 1142
Use of Device Problem 995 995
Electromagnetic Interference 986 986
Filling Problem 978 978
Volume Accuracy Problem 899 899
Aspiration Issue 849 849
Fluid Leak 779 779
Excess Flow or Over-Infusion 738 738
Intermittent Infusion 696 696
Failure To Service 669 669
Unstable 626 626
Inappropriate or Unexpected Reset 458 458
Disconnection 373 373
Occlusion Within Device 332 332
Positioning Problem 290 290
Kinked 275 275
Improper Flow or Infusion 274 274
No Audible Alarm 272 272
Human-Device Interface Problem 251 251
Communication or Transmission Problem 243 243
Device Alarm System 218 218
Appropriate Term/Code Not Available 180 180
Premature Elective Replacement Indicator 170 170
Device Or Device Fragments Location Unknown 166 166
Device Ingredient or Reagent Problem 164 164
Failure to Disconnect 162 162
Battery Problem 155 155
Data Problem 153 153
Patient Device Interaction Problem 142 142
Protective Measures Problem 124 124
Connection Problem 96 96
Mechanical Jam 91 91
Difficult to Advance 83 83
Malposition of Device 82 82
Failure to Interrogate 82 82
Material Split, Cut or Torn 77 77
Migration 69 69
Application Program Problem 68 68
Inadequacy of Device Shape and/or Size 64 64
Nonstandard Device 59 59
No Flow 49 49
Mechanical Problem 45 45
Misconnection 41 41
Leak/Splash 37 37
Difficult to Interrogate 35 35
Material Twisted/Bent 34 34
Ambient Temperature Problem 33 33
Patient-Device Incompatibility 32 32
Device Issue 31 31
Premature End-of-Life Indicator 31 31
Display or Visual Feedback Problem 28 28
Material Deformation 26 26
Vibration 25 25
Device Dislodged or Dislocated 25 25
Activation Failure 22 22
Fracture 21 21
Noise, Audible 20 20
Unintended Electrical Shock 19 19
Unintended Movement 19 19
Particulates 19 19
Suction Problem 19 19
Defective Device 18 18
Decrease in Pressure 18 18
Temperature Problem 18 18
Excessive Heating 16 16
Torn Material 15 15
Break 15 15
Increase in Pressure 13 13
Material Puncture/Hole 13 13
Component Missing 12 12
Therapeutic or Diagnostic Output Failure 12 12
Pumping Problem 11 11
Detachment of Device or Device Component 11 11
Device Operational Issue 11 11
Failure to Deliver 10 10
Overfill 10 10
Shelf Life Exceeded 10 10
Retraction Problem 9 9
Unexpected Therapeutic Results 9 9
Environmental Compatibility Problem 9 9
Contamination 9 9
Output Problem 9 9
Mechanics Altered 8 8
Difficult to Insert 8 8
Loss of Power 7 7
Computer Software Problem 7 7
Activation, Positioning or SeparationProblem 7 7
Material Too Rigid or Stiff 7 7
Defective Component 7 7
Unexpected Shutdown 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10069 10069
Pain 5264 5266
Therapeutic Response, Decreased 4735 4735
No Clinical Signs, Symptoms or Conditions 2418 2418
Unspecified Infection 2178 2179
Complaint, Ill-Defined 2065 2065
Muscular Rigidity 1815 1816
Therapeutic Effects, Unexpected 1773 1775
Overdose 1301 1301
Malaise 859 859
Discomfort 813 813
Seroma 804 804
Insufficient Information 802 802
Nausea 744 744
Cerebrospinal Fluid Leakage 696 696
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 642 642
Muscle Spasm(s) 627 627
Cognitive Changes 618 618
Vomiting 614 614
Swelling 513 513
Ambulation Difficulties 507 507
Loss of consciousness 494 494
Injury 478 478
Fatigue 466 466
Headache 465 465
Wound Dehiscence 428 428
Erythema 423 423
Pocket Erosion 419 420
Fluid Discharge 399 399
Inadequate Pain Relief 382 382
Granuloma 367 367
Fever 336 336
Itching Sensation 335 335
No Code Available 327 327
Underdose 317 317
Shaking/Tremors 312 312
Sweating 308 308
Sleep Dysfunction 298 298
Muscle Weakness 294 294
Numbness 284 284
Anxiety 245 245
Burning Sensation 245 245
Dizziness 237 237
Diarrhea 236 236
Lethargy 234 234
Bacterial Infection 224 224
Post Operative Wound Infection 220 220
Irritability 212 212
Seizures 212 212
Headache, Lumbar Puncture 211 211
Scar Tissue 207 207
Patient Problem/Medical Problem 207 207
Chills 199 199
Purulent Discharge 189 189
Confusion/ Disorientation 186 186
Impaired Healing 185 185
High Blood Pressure/ Hypertension 183 183
Device Embedded In Tissue or Plaque 175 175
Weight Changes 159 160
Alteration In Body Temperature 157 157
Staphylococcus Aureus 141 141
Low Blood Pressure/ Hypotension 140 140
Test Result 132 132
Meningitis 128 128
Weakness 127 127
Fall 123 123
Swelling/ Edema 123 123
Tachycardia 115 115
Sepsis 114 114
Hematoma 114 114
Cramp(s) /Muscle Spasm(s) 114 114
Dyspnea 112 112
Tingling 110 110
Abdominal Pain 104 104
Distress 94 94
Death 93 93
Erosion 90 90
Inflammation 90 90
Hemorrhage/Bleeding 89 89
Dysphasia 88 88
Twiddlers Syndrome 83 83
Memory Loss/Impairment 82 82
Skin Erosion 81 81
Coma 75 75
Cellulitis 72 72
Bruise/Contusion 70 70
Emotional Changes 67 67
Twitching 67 67
Respiratory Distress 66 66
Rash 65 65
Decreased Respiratory Rate 65 65
Diaphoresis 64 64
Sedation 64 64
Foreign Body Reaction 63 63
Abscess 63 63
Neurological Deficit/Dysfunction 61 61
Paralysis 58 58
Electric Shock 56 56
Reaction 55 55
Cramp(s) 54 54

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 Flowonix Medical, Inc. II Jun-19-2017
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 Medtronic Neuromodulation II Mar-29-2017
10 Smiths Medical ASD Inc. II Sep-23-2019
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