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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)
2016 2017 2018 2019 2020 2021
30 42 55 57 49 25

MDR Year MDR Reports MDR Events
2016 8458 8458
2017 7749 7749
2018 6936 6936
2019 5652 5652
2020 5115 5115
2021 3163 3163

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9732 9732
Pumping Stopped 4297 4297
Device Operates Differently Than Expected 3855 3855
Insufficient Flow or Under Infusion 3761 3761
Material Integrity Problem 2833 2833
Migration or Expulsion of Device 2452 2452
Insufficient Information 2409 2409
Device Displays Incorrect Message 2386 2386
Infusion or Flow Problem 2238 2238
Volume Accuracy Problem 1534 1534
Aspiration Issue 1418 1418
Improper or Incorrect Procedure or Method 1413 1413
Obstruction of Flow 1375 1375
Failure To Service 1232 1232
Filling Problem 1172 1172
Intermittent Infusion 1109 1109
Electromagnetic Interference 1107 1107
Unstable 1096 1096
Use of Device Problem 999 999
Fluid Leak 942 942
Excess Flow or Over-Infusion 889 889
Inappropriate or Unexpected Reset 750 750
Occlusion Within Device 549 549
Kinked 479 479
Disconnection 452 452
No Audible Alarm 378 378
Human-Device Interface Problem 307 307
Device Alarm System 307 307
Positioning Problem 299 299
Improper Flow or Infusion 257 257
Device Or Device Fragments Location Unknown 256 256
Communication or Transmission Problem 242 242
Premature Elective Replacement Indicator 226 226
Battery Problem 209 209
Appropriate Term/Code Not Available 205 205
Device Ingredient or Reagent Problem 193 193
Nonstandard Device 191 191
Data Problem 180 180
Failure to Disconnect 177 177
Protective Measures Problem 164 164
Mechanical Jam 139 139
Patient Device Interaction Problem 128 128
Malposition of Device 113 113
Failure to Interrogate 109 109
Connection Problem 106 106
Difficult to Advance 99 99
Application Program Problem 83 83
Inadequacy of Device Shape and/or Size 78 78
Material Split, Cut or Torn 70 70
Migration 59 59
Difficult to Interrogate 58 58
Device Operational Issue 51 51
No Flow 50 50
Mechanical Problem 49 49
Activation Failure 46 46
Device Issue 44 44
Temperature Problem 43 43
Misconnection 43 43
Display or Visual Feedback Problem 38 38
Leak/Splash 37 37
Vibration 37 37
Premature End-of-Life Indicator 36 36
Patient-Device Incompatibility 32 32
Material Twisted/Bent 32 32
Ambient Temperature Problem 31 31
Torn Material 30 30
Noise, Audible 27 27
Material Deformation 27 27
Device Dislodged or Dislocated 22 22
Activation, Positioning or SeparationProblem 21 21
Shelf Life Exceeded 21 21
Suction Problem 19 19
Particulates 19 19
Unintended Movement 19 19
Decrease in Pressure 19 19
Increase in Pressure 18 18
Defective Device 18 18
Break 17 17
Fracture 17 17
Unintended Electrical Shock 17 17
Overfill 15 15
Component Missing 14 14
Material Puncture/Hole 14 14
Pumping Problem 14 14
Excessive Heating 14 14
Failure to Deliver 13 13
Contamination 12 12
Detachment of Device or Device Component 11 11
Environmental Compatibility Problem 11 11
Therapeutic or Diagnostic Output Failure 11 11
Difficult to Insert 10 10
Unexpected Therapeutic Results 10 10
Output Problem 9 9
Off-Label Use 9 9
Difficult To Position 9 9
Loss of Power 8 8
Inaccurate Delivery 8 8
Device Handling Problem 8 8
Missing Value Reason 8 8
Premature Discharge of Battery 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 12900 12900
Pain 6665 6667
Therapeutic Response, Decreased 6349 6349
Complaint, Ill-Defined 2941 2941
Unspecified Infection 2756 2757
Therapeutic Effects, Unexpected 2440 2442
Muscular Rigidity 2379 2380
Overdose 1786 1786
No Clinical Signs, Symptoms or Conditions 1777 1777
Malaise 1119 1119
Discomfort 1019 1019
Seroma 999 999
Nausea 966 966
Muscle Spasm(s) 885 885
Cerebrospinal Fluid Leakage 827 827
Cognitive Changes 783 783
Vomiting 769 769
Ambulation Difficulties 687 687
Swelling 679 679
Loss of consciousness 621 621
Fatigue 599 599
Headache 567 567
Injury 561 561
Insufficient Information 548 548
Erythema 545 545
Fluid Discharge 540 540
Underdose 538 538
Wound Dehiscence 535 535
Granuloma 524 524
Pocket Erosion 493 494
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 488 488
Fever 449 449
Sweating 436 436
Itching Sensation 436 436
Muscle Weakness 401 401
Shaking/Tremors 393 393
Numbness 391 391
Sleep Dysfunction 385 385
No Code Available 375 375
Anxiety 358 358
Inadequate Pain Relief 356 356
Burning Sensation 319 319
Dizziness 311 311
Diarrhea 303 303
Bacterial Infection 300 300
Lethargy 292 292
Post Operative Wound Infection 291 291
Seizures 281 281
Headache, Lumbar Puncture 275 275
Irritability 273 273
Chills 268 268
Scar Tissue 267 267
Staphylococcus Aureus 248 248
Purulent Discharge 242 242
Patient Problem/Medical Problem 241 241
Confusion/ Disorientation 237 237
High Blood Pressure/ Hypertension 232 232
Impaired Healing 226 226
Device Embedded In Tissue or Plaque 225 225
Alteration In Body Temperature 216 216
Weight Changes 212 213
Weakness 202 202
Test Result 193 193
Fall 186 186
Low Blood Pressure/ Hypotension 185 185
Meningitis 173 173
Tachycardia 157 157
Sepsis 157 157
Tingling 155 155
Abdominal Pain 137 137
Distress 136 136
Hematoma 135 135
Dyspnea 132 132
Dysphasia 125 125
Urinary Retention 119 119
Hemorrhage/Bleeding 119 119
Respiratory Distress 118 118
Death 115 115
Skin Erosion 115 115
Twiddlers Syndrome 113 113
Inflammation 109 109
Memory Loss/Impairment 107 107
Emotional Changes 96 96
Swelling/ Edema 96 96
Neurological Deficit/Dysfunction 95 95
Sedation 94 94
Cellulitis 94 94
Erosion 93 93
Abscess 92 92
Coma 86 86
Twitching 86 86
Bruise/Contusion 85 85
Foreign Body Reaction 84 84
Rash 84 84
Cramp(s) /Muscle Spasm(s) 83 83
Cramp(s) 82 82
Constipation 82 82
Electric Shock 82 82
Reaction 77 77
Incontinence 75 75

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 Medtronic Neuromodulation I Dec-19-2016
11 Medtronic Neuromodulation II Mar-29-2016
12 Smiths Medical ASD Inc. II Sep-23-2019
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