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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 10

MDR Year MDR Reports MDR Events
2018 6936 6936
2019 5652 5652
2020 5115 5115
2021 4713 4713
2022 4310 4310
2023 2783 2783

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8023 8023
Insufficient Flow or Under Infusion 3950 3950
Infusion or Flow Problem 3710 3710
Insufficient Information 3484 3484
Pumping Stopped 3413 3413
Migration or Expulsion of Device 3105 3105
Material Integrity Problem 2556 2556
Obstruction of Flow 2147 2147
Electromagnetic Interference 1115 1115
Improper or Incorrect Procedure or Method 1032 1032
Use of Device Problem 996 996
Filling Problem 981 981
Fluid/Blood Leak 814 814
Excess Flow or Over-Infusion 717 717
Device Operates Differently Than Expected 672 672
Device Displays Incorrect Message 474 474
Improper Flow or Infusion 405 405
Disconnection 375 375
Positioning Problem 324 324
Communication or Transmission Problem 312 312
Volume Accuracy Problem 310 310
Aspiration Issue 308 308
Intermittent Infusion 222 222
Unstable 220 220
Failure To Service 212 212
No Audible Alarm 200 200
Human-Device Interface Problem 191 191
Patient Device Interaction Problem 187 187
Device Ingredient or Reagent Problem 175 175
Device Alarm System 173 173
Failure to Disconnect 170 170
Appropriate Term/Code Not Available 162 162
Data Problem 148 148
Inappropriate or Unexpected Reset 134 134
Protective Measures Problem 122 122
Battery Problem 114 114
Connection Problem 104 104
Material Split, Cut or Torn 102 102
Migration 101 101
Kinked 100 100
Occlusion Within Device 100 100
Premature Elective Replacement Indicator 80 80
Difficult to Advance 78 78
Failure to Interrogate 72 72
Application Program Problem 60 60
Inadequacy of Device Shape and/or Size 60 60
Nonstandard Device 58 58
No Flow 58 58
Mechanical Problem 57 57
Device Or Device Fragments Location Unknown 57 57
Material Twisted/Bent 48 48
Misconnection 46 46
Ambient Temperature Problem 45 45
Malposition of Device 41 41
Device Dislodged or Dislocated 41 41
Leak/Splash 41 41
Mechanical Jam 38 38
Material Deformation 34 34
Patient-Device Incompatibility 33 33
Fracture 31 31
Display or Visual Feedback Problem 28 28
Vibration 24 24
Defective Device 22 22
Unintended Electrical Shock 22 22
Retraction Problem 20 20
Particulates 19 19
Suction Problem 19 19
Output Problem 19 19
Therapeutic or Diagnostic Output Failure 19 19
Noise, Audible 19 19
Unintended Movement 18 18
Break 18 18
Material Puncture/Hole 17 17
Excessive Heating 17 17
Increase in Pressure 16 16
Device Issue 15 15
Difficult to Interrogate 14 14
Detachment of Device or Device Component 14 14
Component Missing 13 13
Premature End-of-Life Indicator 12 12
Decrease in Pressure 12 12
Pumping Problem 11 11
Defective Component 10 10
Failure to Deliver 9 9
Activation, Positioning or Separation Problem 9 9
Contamination 9 9
Difficult to Insert 9 9
Temperature Problem 9 9
Unauthorized Access to Computer System 9 9
Mechanics Altered 8 8
Unexpected Shutdown 8 8
Activation Failure 8 8
Environmental Compatibility Problem 8 8
Separation Failure 8 8
Unexpected Therapeutic Results 8 8
Inaccurate Delivery 7 7
Component or Accessory Incompatibility 7 7
Material Too Rigid or Stiff 7 7
Loss of Power 6 6
Computer Software Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7029 7029
No Clinical Signs, Symptoms or Conditions 5328 5328
Pain 4935 4937
Therapeutic Response, Decreased 3203 3203
Unspecified Infection 2261 2262
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1710 1710
Muscular Rigidity 1674 1675
Insufficient Information 1614 1614
Complaint, Ill-Defined 1300 1300
Therapeutic Effects, Unexpected 1172 1174
Seroma 853 853
Discomfort 831 831
Overdose 821 821
Cerebrospinal Fluid Leakage 742 742
Malaise 659 659
Nausea 640 640
Cognitive Changes 539 539
Vomiting 521 521
Headache 514 514
Inadequate Pain Relief 513 513
Wound Dehiscence 461 461
Loss of consciousness 452 452
Pocket Erosion 445 446
Ambulation Difficulties 423 423
Fatigue 402 402
Erythema 394 394
Muscle Spasm(s) 393 393
Fluid Discharge 381 381
Swelling 342 342
Itching Sensation 317 317
Granuloma 307 307
Fever 299 299
Muscle Weakness 284 284
No Code Available 279 279
Swelling/ Edema 272 272
Numbness 265 265
Sleep Dysfunction 254 254
Shaking/Tremors 246 246
Post Operative Wound Infection 240 240
Cramp(s) /Muscle Spasm(s) 236 236
Bacterial Infection 226 226
Burning Sensation 207 207
Diarrhea 202 202
Lethargy 202 202
Impaired Healing 200 200
Scar Tissue 198 198
Sweating 195 195
Dizziness 193 193
Purulent Discharge 190 190
Device Embedded In Tissue or Plaque 188 188
Anxiety 184 184
Underdose 184 184
Irritability 166 166
Confusion/ Disorientation 165 165
Headache, Lumbar Puncture 165 165
Chills 162 162
High Blood Pressure/ Hypertension 154 154
Patient Problem/Medical Problem 151 151
Seizures 144 144
Weight Changes 137 138
Low Blood Pressure/ Hypotension 136 136
Diaphoresis 126 126
Meningitis 123 123
Dyspnea 116 116
Fall 114 114
Hematoma 113 113
Sepsis 110 110
Tachycardia 104 104
Convulsion/Seizure 104 104
Alteration In Body Temperature 103 103
Inflammation 96 96
Hemorrhage/Bleeding 92 92
Staphylococcus Aureus 87 87
Erosion 87 87
Test Result 86 86
Abdominal Pain 85 85
Dysphasia 81 81
Injury 81 81
Weakness 79 79
Skin Erosion 78 78
Foreign Body Reaction 72 72
Bruise/Contusion 71 71
Distress 71 71
Decreased Respiratory Rate 71 71
Twiddlers Syndrome 71 71
Tingling 69 69
Abscess 65 65
Rash 64 64
Cellulitis 63 63
Coma 63 63
Apnea 61 61
Emotional Changes 61 61
Memory Loss/Impairment 59 59
Alteration in Body Temperature 55 55
Bradycardia 54 54
Twiddlers Syndrome 54 54
Paralysis 53 53
Twitching 51 51
Urinary Retention 51 51
Constipation 49 49

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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