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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)
2015 2016 2017 2018 2019 2020
40 30 42 55 57 35

MDR Year MDR Reports MDR Events
2015 8445 8445
2016 8454 8454
2017 7750 7750
2018 6932 6932
2019 5650 5650
2020 3785 3785

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10755 10755
Device Operates Differently Than Expected 5330 5330
Pumping Stopped 4369 4369
Insufficient Flow or Under Infusion 3509 3509
Device Displays Incorrect Message 3391 3391
Material Integrity Problem 2984 2984
Migration or Expulsion of Device 2186 2186
Volume Accuracy Problem 2127 2127
Insufficient Information 1950 1950
Aspiration Issue 1859 1859
Failure To Service 1741 1741
Improper or Incorrect Procedure or Method 1596 1596
Unstable 1548 1548
Infusion or Flow Problem 1514 1514
Intermittent Infusion 1427 1427
Filling Problem 1248 1248
Electromagnetic Interference 1057 1057
Fluid Leak 1026 1026
Obstruction of Flow 971 971
Excess Flow or Over-Infusion 935 935
Use of Device Problem 915 915
Inappropriate or Unexpected Reset 872 872
Occlusion Within Device 783 783
Kinked 663 663
Nonstandard Device 647 647
Disconnection 487 487
No Audible Alarm 459 459
Device Or Device Fragments Location Unknown 398 398
Device Alarm System 379 379
Human-Device Interface Problem 371 371
Positioning Problem 276 276
Communication or Transmission Problem 248 248
Battery Problem 246 246
Premature Elective Replacement Indicator 240 240
Appropriate Term/Code Not Available 220 220
Device Ingredient or Reagent Problem 218 218
Failure to Disconnect 207 207
Data Problem 193 193
Improper Flow or Infusion 181 181
Mechanical Jam 172 172
Protective Measures Problem 164 164
Malposition of Device 141 141
Failure to Interrogate 128 128
Connection Problem 108 108
Application Program Problem 104 104
Difficult to Advance 98 98
Patient Device Interaction Problem 94 94
Inadequacy of Device Shape and/or Size 88 88
Difficult to Interrogate 83 83
Catheter 71 71
Activation Failure 67 67
Temperature Problem 56 56
Device Operational Issue 54 54
Device Issue 51 51
Torn Material 48 48
Motor(s) 48 48
Mechanical Problem 46 46
Shelf Life Exceeded 45 45
Misconnection 45 45
Activation, Positioning or SeparationProblem 44 44
Vibration 41 41
Material Split, Cut or Torn 39 39
Display or Visual Feedback Problem 38 38
Premature End-of-Life Indicator 38 38
Noise, Audible 37 37
No Flow 35 35
Patient-Device Incompatibility 30 30
Pump 26 26
Environmental Compatibility Problem 25 25
Leak/Splash 25 25
Material Deformation 25 25
Break 23 23
Difficult To Position 23 23
Ambient Temperature Problem 22 22
Increase in Pressure 22 22
Contamination 21 21
Decrease in Pressure 19 19
Unintended Movement 19 19
Particulates 19 19
Suction Problem 19 19
Defective Device 17 17
Overfill 17 17
Component Missing 16 16
Material Twisted/Bent 16 16
Pumping Problem 15 15
Unintended Electrical Shock 14 14
Failure to Deliver 14 14
High impedance 14 14
Migration 12 12
Excessive Heating 11 11
Difficult to Insert 11 11
Changes In Ambient Temperature In Device Environment 11 11
Material Puncture/Hole 10 10
Premature Discharge of Battery 10 10
Unexpected Therapeutic Results 10 10
Inadequate or Insufficient Training 9 9
Inaccurate Delivery 9 9
Loss of Power 9 9
Detachment of Device or Device Component 9 9
Device Damaged by Another Device 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 15150 15150
Therapeutic Response, Decreased 7560 7560
Pain 7282 7282
Complaint, Ill-Defined 3775 3775
Therapeutic Effects, Unexpected 3111 3111
Unspecified Infection 2908 2909
Muscular Rigidity 2763 2764
Overdose 2327 2327
Malaise 1321 1321
Discomfort 1115 1115
Muscle Spasm(s) 1112 1112
Seroma 1073 1073
Nausea 1025 1025
Cognitive Changes 938 938
Cerebrospinal Fluid Leakage 890 890
Vomiting 846 846
Swelling 819 819
Underdose 809 809
Ambulation Difficulties 799 799
Loss of consciousness 733 733
Granuloma 659 659
Fatigue 647 647
Injury 617 617
Headache 616 616
Fluid Discharge 611 611
Wound Dehiscence 577 577
Erythema 557 557
Sweating 557 557
Pocket Erosion 520 520
Itching Sensation 492 492
Fever 484 484
Shaking/Tremors 469 469
Muscle Weakness 468 468
No Code Available 446 446
Sleep Dysfunction 441 441
Numbness 437 437
Anxiety 393 393
Staphylococcus Aureus 365 365
Burning Sensation 348 348
Dizziness 347 347
Irritability 343 343
Seizures 335 335
Lethargy 328 328
Headache, Lumbar Puncture 326 326
Diarrhea 317 317
Post Operative Wound Infection 302 302
Bacterial Infection 296 296
Chills 295 295
Alteration In Body Temperature 276 276
Weight Changes 274 274
Scar Tissue 274 274
Weakness 268 268
Confusion/ Disorientation 268 268
Purulent Discharge 266 266
Test Result 263 263
High Blood Pressure/ Hypertension 249 249
Patient Problem/Medical Problem 248 248
Urinary Retention 238 238
Impaired Healing 235 235
Device Embedded In Tissue or Plaque 231 231
Fall 226 226
Inadequate Pain Relief 224 224
Meningitis 211 211
Tingling 205 205
Low Blood Pressure/ Hypotension 199 199
Tachycardia 189 189
Death 180 180
Sepsis 170 170
Distress 169 169
Respiratory Distress 157 157
Dysphasia 146 146
Hematoma 143 143
Neurological Deficit/Dysfunction 138 138
Abdominal Pain 138 138
Dyspnea 136 136
Skin Erosion 135 135
Twiddlers Syndrome 133 133
Hemorrhage/Bleeding 121 121
Memory Loss/Impairment 118 118
Sedation 116 116
Cramp(s) 115 115
Emotional Changes 115 115
Twitching 112 112
Constipation 108 108
Coma 105 105
Reaction 103 103
Inflammation 102 102
No Information 99 99
Abscess 98 98
Cellulitis 97 97
Electric Shock 96 96
Incontinence 92 92
Rash 92 92
Respiratory Failure 91 91
No Consequences Or Impact To Patient 90 90
Erosion 89 89
Bruise/Contusion 89 89
Irritation 86 86
Hypersensitivity/Allergic reaction 86 86
Foreign Body Reaction 85 85

Recalls
Manufacturer Recall Class Date Posted
1 Codman & Shurtleff, Inc. II May-28-2015
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 Medtronic Neuromodulation II May-28-2015
13 Smiths Medical ASD Inc. II Sep-23-2019
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