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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
10 29 34 33 33 28 40 30 42 55 57 49 32 32 19 6

MDR Year MDR Reports MDR Events
2014 7457 7457
2015 8451 8451
2016 8458 8458
2017 7749 7749
2018 6936 6936
2019 5652 5652
2020 5115 5115
2021 4713 4713
2022 4310 4310
2023 4042 4042
2024 1472 1472

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17329 17329
Device Operates Differently Than Expected 6761 6761
Pumping Stopped 6113 6113
Insufficient Flow or Under Infusion 5715 5715
Material Integrity Problem 5099 5099
Migration or Expulsion of Device 4546 4546
Infusion or Flow Problem 4149 4149
Device Displays Incorrect Message 4131 4131
Insufficient Information 4041 4041
Volume Accuracy Problem 2748 2748
Improper or Incorrect Procedure or Method 2501 2501
Obstruction of Flow 2390 2390
Aspiration Issue 2316 2316
Failure To Service 2048 2048
Unstable 2023 2023
Filling Problem 1972 1972
Electromagnetic Interference 1921 1921
Fluid/Blood Leak 1680 1680
Intermittent Infusion 1656 1656
Excess Flow or Over-Infusion 1507 1507
Occlusion Within Device 1042 1042
Use of Device Problem 1036 1036
Inappropriate or Unexpected Reset 993 993
Nonstandard Device 943 943
Kinked 875 875
Disconnection 815 815
No Audible Alarm 620 620
Device Alarm System 550 550
Positioning Problem 532 532
Human-Device Interface Problem 528 528
Communication or Transmission Problem 526 526
Device Or Device Fragments Location Unknown 525 525
Improper Flow or Infusion 477 477
Device Ingredient or Reagent Problem 360 360
Battery Problem 347 347
Failure to Disconnect 331 331
Data Problem 330 330
Appropriate Term/Code Not Available 291 291
Premature Elective Replacement Indicator 266 266
Protective Measures Problem 236 236
Mechanical Jam 204 204
Failure to Interrogate 202 202
Patient Device Interaction Problem 200 200
Application Program Problem 199 199
Connection Problem 193 193
Malposition of Device 190 190
Difficult to Advance 172 172
Inadequacy of Device Shape and/or Size 143 143
Difficult to Interrogate 118 118
Material Split, Cut or Torn 109 109
Migration 103 103
Activation Failure 87 87
Activation, Positioning or Separation Problem 79 79
Misconnection 77 77
No Flow 76 76
Torn Material 71 71
Temperature Problem 68 68
Mechanical Problem 64 64
Vibration 61 61
Shelf Life Exceeded 55 55
Material Twisted/Bent 55 55
Device Operational Issue 54 54
Noise, Audible 54 54
Leak/Splash 54 54
Device Issue 51 51
Ambient Temperature Problem 51 51
Material Deformation 45 45
Device Dislodged or Dislocated 42 42
Premature End-of-Life Indicator 42 42
Break 38 38
Display or Visual Feedback Problem 38 38
Particulates 37 37
Fracture 36 36
Patient-Device Incompatibility 34 34
Difficult To Position 33 33
Increase in Pressure 31 31
Contamination 29 29
Material Puncture/Hole 27 27
Component Missing 27 27
Environmental Compatibility Problem 27 27
Unintended Electrical Shock 26 26
Decrease in Pressure 26 26
Defective Device 25 25
Excessive Heating 23 23
Therapeutic or Diagnostic Output Failure 22 22
Unintended Movement 21 21
Overfill 20 20
Retraction Problem 20 20
Suction Problem 19 19
Changes In Ambient Temperature In Device Environment 19 19
Difficult to Insert 19 19
Output Problem 19 19
Separation Failure 17 17
High impedance 16 16
Bent 16 16
Pumping Problem 16 16
Detachment of Device or Device Component 15 15
Failure to Deliver 15 15
Inaccurate Delivery 14 14
Off-Label Use 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 17566 17566
Pain 10996 10998
Therapeutic Response, Decreased 8906 8906
No Clinical Signs, Symptoms or Conditions 6554 6554
Complaint, Ill-Defined 4618 4618
Unspecified Infection 4584 4585
Muscular Rigidity 4324 4325
Therapeutic Effects, Unexpected 4000 4002
Overdose 2988 2988
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2270 2270
Insufficient Information 1899 1899
Discomfort 1816 1816
Seroma 1815 1815
Malaise 1802 1802
Cerebrospinal Fluid Leakage 1532 1532
Cognitive Changes 1460 1460
Nausea 1449 1449
Muscle Spasm(s) 1404 1404
Vomiting 1221 1221
Ambulation Difficulties 1167 1167
Underdose 1151 1151
Loss of consciousness 1110 1110
Headache 1100 1100
Swelling 984 984
Wound Dehiscence 960 960
Fatigue 954 954
Granuloma 949 949
Fluid Discharge 915 915
Pocket Erosion 857 858
Erythema 851 851
Muscle Weakness 775 775
Itching Sensation 719 719
Fever 710 710
Numbness 671 671
Sweating 671 671
Shaking/Tremors 656 656
Injury 644 644
Inadequate Pain Relief 630 630
Sleep Dysfunction 623 623
No Code Available 579 579
Bacterial Infection 520 520
Post Operative Wound Infection 515 515
Burning Sensation 511 511
Anxiety 510 510
Dizziness 501 501
Lethargy 491 491
Irritability 481 481
Staphylococcus Aureus 467 467
Scar Tissue 453 453
Diarrhea 438 438
Purulent Discharge 422 422
Chills 419 419
Seizures 407 407
Device Embedded In Tissue or Plaque 401 401
Headache, Lumbar Puncture 397 397
Weight Changes 395 396
Confusion/ Disorientation 390 390
Impaired Healing 388 388
High Blood Pressure/ Hypertension 359 359
Test Result 350 350
Weakness 349 349
Swelling/ Edema 341 341
Alteration In Body Temperature 328 328
Low Blood Pressure/ Hypotension 317 317
Fall 316 316
Meningitis 316 316
Urinary Retention 302 302
Cramp(s) /Muscle Spasm(s) 283 283
Tachycardia 277 277
Tingling 268 268
Sepsis 261 261
Patient Problem/Medical Problem 247 247
Hematoma 235 235
Distress 233 233
Death 227 227
Skin Erosion 218 218
Dysphasia 211 211
Respiratory Distress 204 204
Hemorrhage/Bleeding 197 197
Dyspnea 192 192
Inflammation 187 187
Abdominal Pain 182 182
Neurological Deficit/Dysfunction 179 179
Emotional Changes 176 176
Coma 172 172
Reaction 169 169
Twitching 165 165
Diaphoresis 158 158
Bruise/Contusion 153 153
Twiddlers Syndrome 152 152
Foreign Body Reaction 150 150
Memory Loss/Impairment 148 148
Abscess 144 144
Constipation 143 143
Erosion 142 142
Rash 140 140
Cramp(s) 137 137
Electric Shock 137 137
Sedation 135 135
Cellulitis 135 135

Recalls
Manufacturer Recall Class Date Posted
1 Codman & Shurtleff, Inc. II May-28-2015
2 Codman & Shurtleff, Inc. II May-09-2014
3 Codman & Shurtleff, Inc. I Sep-30-2013
4 Codman & Shurtleff, Inc. I Jul-16-2013
5 Flowonix Medical Inc II Jul-01-2021
6 Flowonix Medical Inc II Feb-10-2020
7 Flowonix Medical Inc II Jun-03-2019
8 Flowonix Medical, Inc. II Jun-19-2017
9 Intera Oncology, Inc. I Aug-22-2022
10 Medtronic Inc. II Dec-09-2023
11 Medtronic Inc. II Jun-03-2020
12 Medtronic Neuromodulation II Dec-22-2023
13 Medtronic Neuromodulation I Dec-03-2019
14 Medtronic Neuromodulation II Mar-03-2018
15 Medtronic Neuromodulation III Feb-06-2018
16 Medtronic Neuromodulation II Mar-29-2017
17 Medtronic Neuromodulation I Dec-19-2016
18 Medtronic Neuromodulation II Mar-29-2016
19 Medtronic Neuromodulation II May-28-2015
20 Medtronic Neuromodulation II Aug-08-2014
21 Medtronic Neuromodulation II Jun-04-2014
22 Medtronic Neuromodulation II May-08-2014
23 Medtronic Neuromodulation II May-08-2014
24 Medtronic Neuromodulation I Jun-25-2013
25 Medtronic Neuromodulation I Jun-25-2013
26 Medtronic Neuromodulation I Jun-24-2013
27 Medtronic Neuromodulation I Dec-13-2012
28 Medtronic Neuromodulation II Mar-30-2012
29 Medtronic Neuromodulation II Mar-29-2010
30 Medtronic Neuromodulation II Sep-29-2009
31 Medtronic Neuromodulation I Sep-10-2009
32 Medtronic Neuromodulation II Jan-26-2009
33 Medtronic, Inc. - Neuromodulation I Aug-29-2011
34 Medtronic, Inc. - Neuromodulation I Feb-10-2011
35 Medtronic, Inc. - Neuromodulation II Nov-09-2010
36 Smiths Medical ASD Inc. II Sep-23-2019
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