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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 15

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 3093 3093

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17758 17758
Device Operates Differently Than Expected 6761 6761
Pumping Stopped 6236 6237
Insufficient Flow or Under Infusion 5919 5919
Material Integrity Problem 5209 5209
Migration or Expulsion of Device 4700 4700
Infusion or Flow Problem 4374 4374
Insufficient Information 4266 4266
Device Displays Incorrect Message 4131 4131
Volume Accuracy Problem 2748 2748
Improper or Incorrect Procedure or Method 2547 2547
Obstruction of Flow 2502 2502
Aspiration Issue 2316 2316
Failure To Service 2048 2048
Filling Problem 2026 2026
Unstable 2023 2023
Electromagnetic Interference 2017 2017
Fluid/Blood Leak 1733 1733
Intermittent Infusion 1656 1656
Excess Flow or Over-Infusion 1539 1539
Occlusion Within Device 1042 1042
Use of Device Problem 1036 1036
Inappropriate or Unexpected Reset 997 997
Nonstandard Device 943 943
Kinked 875 875
Disconnection 832 832
Device Alarm System 687 688
No Audible Alarm 631 631
Communication or Transmission Problem 600 600
Positioning Problem 559 559
Human-Device Interface Problem 534 534
Device Or Device Fragments Location Unknown 525 525
Improper Flow or Infusion 504 504
Device Ingredient or Reagent Problem 366 366
Battery Problem 360 360
Failure to Disconnect 343 343
Data Problem 343 343
Appropriate Term/Code Not Available 323 323
Premature Elective Replacement Indicator 267 267
Protective Measures Problem 247 247
Application Program Problem 219 219
Patient Device Interaction Problem 210 210
Failure to Interrogate 206 206
Mechanical Jam 204 204
Connection Problem 196 196
Malposition of Device 190 190
Difficult to Advance 174 174
Inadequacy of Device Shape and/or Size 145 145
Difficult to Interrogate 118 118
Material Split, Cut or Torn 110 110

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 17566 17566
Pain 11211 11213
Therapeutic Response, Decreased 8906 8906
No Clinical Signs, Symptoms or Conditions 7403 7404
Unspecified Infection 4694 4695
Complaint, Ill-Defined 4618 4618
Muscular Rigidity 4388 4389
Therapeutic Effects, Unexpected 4000 4002
Overdose 2988 2988
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2554 2554
Insufficient Information 2018 2018
Seroma 1865 1865
Discomfort 1861 1861
Malaise 1822 1822
Cerebrospinal Fluid Leakage 1564 1564
Cognitive Changes 1481 1481
Nausea 1468 1468
Muscle Spasm(s) 1404 1404
Vomiting 1235 1235
Ambulation Difficulties 1186 1186
Underdose 1151 1151
Headache 1123 1123
Loss of consciousness 1122 1122
Wound Dehiscence 988 988
Swelling 984 984
Fatigue 969 969
Granuloma 956 956
Fluid Discharge 930 930
Pocket Erosion 876 877
Erythema 868 868
Muscle Weakness 788 788
Itching Sensation 732 732
Fever 716 716
Numbness 683 683
Sweating 671 671
Shaking/Tremors 664 664
Injury 644 644
Inadequate Pain Relief 633 633
Sleep Dysfunction 629 629
No Code Available 579 579
Post Operative Wound Infection 529 529
Bacterial Infection 528 528
Burning Sensation 517 517
Anxiety 516 516
Dizziness 505 505
Lethargy 501 501
Irritability 487 487
Staphylococcus Aureus 467 467
Scar Tissue 464 464
Diarrhea 450 450

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 Jul-12-2024
13 Medtronic Neuromodulation II Dec-22-2023
14 Medtronic Neuromodulation I Dec-03-2019
15 Medtronic Neuromodulation II Mar-03-2018
16 Medtronic Neuromodulation III Feb-06-2018
17 Medtronic Neuromodulation II Mar-29-2017
18 Medtronic Neuromodulation I Dec-19-2016
19 Medtronic Neuromodulation II Mar-29-2016
20 Medtronic Neuromodulation II May-28-2015
21 Medtronic Neuromodulation II Aug-08-2014
22 Medtronic Neuromodulation II Jun-04-2014
23 Medtronic Neuromodulation II May-08-2014
24 Medtronic Neuromodulation II May-08-2014
25 Medtronic Neuromodulation I Jun-25-2013
26 Medtronic Neuromodulation I Jun-25-2013
27 Medtronic Neuromodulation I Jun-24-2013
28 Medtronic Neuromodulation I Dec-13-2012
29 Medtronic Neuromodulation II Mar-30-2012
30 Medtronic Neuromodulation II Mar-29-2010
31 Medtronic Neuromodulation II Sep-29-2009
32 Medtronic Neuromodulation I Sep-10-2009
33 Medtronic Neuromodulation II Jan-26-2009
34 Medtronic, Inc. - Neuromodulation I Aug-29-2011
35 Medtronic, Inc. - Neuromodulation I Feb-10-2011
36 Medtronic, Inc. - Neuromodulation II Nov-09-2010
37 Smiths Medical ASD Inc. II Sep-23-2019
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