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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device pump, infusion, implanted, programmable
Product CodeLKK
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
49 32 32 19 22 2

MDR Year MDR Reports MDR Events
2020 5115 5115
2021 4713 4713
2022 4310 4310
2023 4042 4042
2024 4619 4619
2025 367 367

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6431 6431
Infusion or Flow Problem 3543 3543
Insufficient Information 2999 2999
Insufficient Flow or Under Infusion 2966 2966
Migration or Expulsion of Device 2818 2818
Pumping Stopped 2112 2113
Material Integrity Problem 2077 2077
Obstruction of Flow 1965 1965
Electromagnetic Interference 1040 1040
Filling Problem 775 775
Improper or Incorrect Procedure or Method 749 749
Fluid/Blood Leak 674 674
Excess Flow or Over-Infusion 553 553
Communication or Transmission Problem 486 486
Device Alarm System 411 412
Improper Flow or Infusion 384 384
Use of Device Problem 345 345
Disconnection 289 289
Positioning Problem 288 288
Charging Problem 157 157
Patient Device Interaction Problem 156 156
Data Problem 145 145
No Audible Alarm 130 130
Failure to Disconnect 129 129
Device Ingredient or Reagent Problem 128 128
Application Program Problem 103 103
Protective Measures Problem 101 101
Human-Device Interface Problem 99 99
Migration 97 97
Material Split, Cut or Torn 83 83
Battery Problem 79 79
Connection Problem 78 78
Appropriate Term/Code Not Available 76 76
Inappropriate or Unexpected Reset 74 74
Difficult to Advance 64 64
Failure to Interrogate 57 57
Inadequacy of Device Shape and/or Size 54 54
No Flow 52 52
Material Twisted/Bent 42 42
Device Dislodged or Dislocated 38 38
Ambient Temperature Problem 38 38
Premature Elective Replacement Indicator 36 36
Misconnection 31 31
Fracture 28 28
Leak/Splash 27 27
Mechanical Problem 22 22
Display or Visual Feedback Problem 21 21
Material Deformation 19 19
Excessive Heating 19 19
Vibration 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8374 8375
Pain 3505 3505
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2793 2793
Insufficient Information 2104 2104
No Known Impact Or Consequence To Patient 1936 1936
Unspecified Infection 1811 1811
Muscular Rigidity 1214 1214
Therapeutic Response, Decreased 844 844
Seroma 714 714
Discomfort 632 632
Cerebrospinal Fluid Leakage 626 626
Headache 447 447
Inadequate Pain Relief 422 422
Nausea 407 407
Swelling/ Edema 400 400
Wound Dehiscence 394 394
Malaise 364 364
Pocket Erosion 359 359
Cognitive Changes 357 357
Vomiting 321 321
Cramp(s) /Muscle Spasm(s) 315 315
Complaint, Ill-Defined 308 308
Erythema 305 305
Loss of consciousness 300 300
Therapeutic Effects, Unexpected 286 286
Ambulation Difficulties 281 281
Fluid Discharge 269 269
Fatigue 263 263
Muscle Weakness 233 233
Itching Sensation 214 214
Post Operative Wound Infection 212 212
Fever 200 200
Numbness 197 197
Bacterial Infection 195 195
Impaired Healing 180 180
Granuloma 180 180
Scar Tissue 176 176
Diaphoresis 171 171
Sleep Dysfunction 170 170
Overdose 166 166
Device Embedded In Tissue or Plaque 156 156
Purulent Discharge 151 151
Shaking/Tremors 145 145
Lethargy 135 135
Diarrhea 131 131
Convulsion/Seizure 129 129
Anxiety 128 128
Burning Sensation 127 127
Dizziness 126 126
Confusion/ Disorientation 102 102

Recalls
Manufacturer Recall Class Date Posted
1 Flowonix Medical Inc II Jul-01-2021
2 Flowonix Medical Inc II Feb-10-2020
3 Intera Oncology, Inc. I Aug-22-2022
4 Medtronic Inc. II Dec-09-2023
5 Medtronic Inc. II Jun-03-2020
6 Medtronic Neuromodulation II Dec-27-2024
7 Medtronic Neuromodulation II Oct-21-2024
8 Medtronic Neuromodulation II Jul-12-2024
9 Medtronic Neuromodulation II Dec-22-2023
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