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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 27

MDR Year MDR Reports MDR Events
2017 7749 7749
2018 6936 6936
2019 5652 5652
2020 5115 5115
2021 4713 4713
2022 2862 2862

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8631 8631
Pumping Stopped 3996 3996
Insufficient Flow or Under Infusion 3905 3905
Infusion or Flow Problem 2996 2996
Insufficient Information 2883 2883
Migration or Expulsion of Device 2813 2813
Material Integrity Problem 2687 2687
Device Operates Differently Than Expected 2374 2374
Obstruction of Flow 1766 1766
Device Displays Incorrect Message 1408 1408
Improper or Incorrect Procedure or Method 1228 1228
Electromagnetic Interference 1107 1107
Filling Problem 1061 1061
Use of Device Problem 1000 1000
Volume Accuracy Problem 899 899
Fluid Leak 865 865
Aspiration Issue 849 849
Excess Flow or Over-Infusion 809 809
Intermittent Infusion 696 696
Failure To Service 669 669
Unstable 626 626
Inappropriate or Unexpected Reset 466 466
Disconnection 404 404
Occlusion Within Device 332 332
Improper Flow or Infusion 323 323
Positioning Problem 314 314
No Audible Alarm 285 285
Communication or Transmission Problem 280 280
Kinked 275 275
Human-Device Interface Problem 260 260
Device Alarm System 224 224
Device Ingredient or Reagent Problem 185 185
Appropriate Term/Code Not Available 181 181
Failure to Disconnect 175 175
Premature Elective Replacement Indicator 172 172
Data Problem 167 167
Device Or Device Fragments Location Unknown 166 166
Battery Problem 162 162
Patient Device Interaction Problem 158 158
Protective Measures Problem 137 137
Connection Problem 112 112
Failure to Interrogate 92 92
Material Split, Cut or Torn 92 92
Mechanical Jam 91 91
Difficult to Advance 89 89
Malposition of Device 82 82
Migration 82 82
Application Program Problem 70 70
Inadequacy of Device Shape and/or Size 67 67
Nonstandard Device 59 59
Mechanical Problem 53 53
No Flow 51 51
Material Twisted/Bent 45 45
Misconnection 45 45
Leak/Splash 41 41
Ambient Temperature Problem 36 36
Difficult to Interrogate 35 35
Patient-Device Incompatibility 33 33
Device Dislodged or Dislocated 32 32
Device Issue 31 31
Premature End-of-Life Indicator 31 31
Material Deformation 31 31
Fracture 29 29
Display or Visual Feedback Problem 28 28
Vibration 25 25
Activation Failure 22 22
Unintended Electrical Shock 21 21
Noise, Audible 20 20
Unintended Movement 19 19
Suction Problem 19 19
Particulates 19 19
Decrease in Pressure 18 18
Defective Device 18 18
Temperature Problem 18 18
Excessive Heating 17 17
Break 16 16
Increase in Pressure 15 15
Torn Material 15 15
Material Puncture/Hole 14 14
Component Missing 13 13
Retraction Problem 13 13
Therapeutic or Diagnostic Output Failure 13 13
Detachment of Device or Device Component 13 13
Pumping Problem 11 11
Device Operational Issue 11 11
Shelf Life Exceeded 10 10
Unexpected Therapeutic Results 10 10
Failure to Deliver 10 10
Overfill 10 10
Contamination 10 10
Difficult to Insert 9 9
Environmental Compatibility Problem 9 9
Output Problem 9 9
Mechanics Altered 8 8
Inaccurate Delivery 8 8
Defective Component 7 7
Material Too Rigid or Stiff 7 7
Activation, Positioning or SeparationProblem 7 7
Separation Failure 7 7
Loss of Power 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10069 10069
Pain 5705 5707
Therapeutic Response, Decreased 4735 4735
No Clinical Signs, Symptoms or Conditions 3590 3590
Unspecified Infection 2390 2391
Complaint, Ill-Defined 2065 2065
Muscular Rigidity 1951 1952
Therapeutic Effects, Unexpected 1773 1775
Overdose 1301 1301
Insufficient Information 1163 1163
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 980 980
Discomfort 906 906
Malaise 894 894
Seroma 891 891
Nausea 798 798
Cerebrospinal Fluid Leakage 776 776
Cognitive Changes 674 674
Vomiting 656 656
Muscle Spasm(s) 627 627
Ambulation Difficulties 539 539
Loss of consciousness 535 535
Headache 515 515
Swelling 513 513
Fatigue 501 501
Injury 478 478
Wound Dehiscence 476 476
Inadequate Pain Relief 470 470
Erythema 464 464
Pocket Erosion 464 465
Fluid Discharge 425 425
Granuloma 391 391
Itching Sensation 368 368
Fever 358 358
Shaking/Tremors 343 343
Muscle Weakness 330 330
No Code Available 327 327
Sleep Dysfunction 321 321
Underdose 317 317
Sweating 308 308
Numbness 301 301
Diarrhea 264 264
Anxiety 260 260
Burning Sensation 256 256
Bacterial Infection 250 250
Dizziness 249 249
Lethargy 249 249
Post Operative Wound Infection 240 240
Scar Tissue 225 225
Irritability 223 223
Chills 217 217
Seizures 212 212
Headache, Lumbar Puncture 211 211
Patient Problem/Medical Problem 207 207
Purulent Discharge 205 205
Confusion/ Disorientation 203 203
Impaired Healing 201 201
High Blood Pressure/ Hypertension 200 200
Device Embedded In Tissue or Plaque 197 197
Swelling/ Edema 189 189
Cramp(s) /Muscle Spasm(s) 170 170
Weight Changes 166 167
Alteration In Body Temperature 157 157
Low Blood Pressure/ Hypotension 152 152
Staphylococcus Aureus 141 141
Meningitis 138 138
Fall 134 134
Test Result 132 132
Tachycardia 128 128
Weakness 127 127
Sepsis 126 126
Hematoma 123 123
Dyspnea 116 116
Abdominal Pain 110 110
Tingling 110 110
Distress 105 105
Inflammation 103 103
Hemorrhage/Bleeding 99 99
Erosion 94 94
Death 93 93
Dysphasia 91 91
Diaphoresis 88 88
Memory Loss/Impairment 87 87
Skin Erosion 85 85
Twiddlers Syndrome 83 83
Coma 79 79
Cellulitis 77 77
Convulsion/Seizure 77 77
Decreased Respiratory Rate 76 76
Bruise/Contusion 75 75
Emotional Changes 74 74
Rash 73 73
Twitching 73 73
Abscess 71 71
Foreign Body Reaction 70 70
Respiratory Distress 66 66
Paralysis 65 65
Sedation 64 64
Electric Shock 62 62
Neurological Deficit/Dysfunction 61 61
Apnea 60 60

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 Intera Oncology, Inc. I Aug-22-2022
6 Medtronic Inc. II Jun-03-2020
7 Medtronic Neuromodulation I Dec-03-2019
8 Medtronic Neuromodulation II Mar-03-2018
9 Medtronic Neuromodulation III Feb-06-2018
10 Medtronic Neuromodulation II Mar-29-2017
11 Smiths Medical ASD Inc. II Sep-23-2019
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