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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 9

MDR Year MDR Reports MDR Events
2020 5115 5115
2021 4713 4713
2022 4310 4310
2023 4041 4041
2024 4619 4619
2025 2385 2385

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6868 6868
Infusion or Flow Problem 3728 3728
Insufficient Information 3189 3189
Insufficient Flow or Under Infusion 3132 3132
Migration or Expulsion of Device 2961 2961
Pumping Stopped 2196 2196
Material Integrity Problem 2178 2178
Obstruction of Flow 2070 2070
Communication or Transmission Problem 1175 1175
Electromagnetic Interference 1107 1107
Filling Problem 821 821
Improper or Incorrect Procedure or Method 777 777
Fluid/Blood Leak 713 713
Excess Flow or Over-Infusion 597 597
Device Alarm System 486 486
Improper Flow or Infusion 409 409
Use of Device Problem 348 348
Positioning Problem 312 312
Disconnection 305 305
Application Program Problem 268 268
Charging Problem 236 236
Patient Device Interaction Problem 171 171
Data Problem 163 163
Protective Measures Problem 142 142
Failure to Disconnect 142 142
No Audible Alarm 138 138
Device Ingredient or Reagent Problem 131 131
Human-Device Interface Problem 105 105
Migration 98 98
Battery Problem 94 94
Material Split, Cut or Torn 85 85
Appropriate Term/Code Not Available 84 84
Connection Problem 82 82
Inappropriate or Unexpected Reset 78 78
Difficult to Advance 67 67
No Flow 60 60
Failure to Interrogate 57 57
Inadequacy of Device Shape and/or Size 56 56
Display or Visual Feedback Problem 47 47
Material Twisted/Bent 45 45
Ambient Temperature Problem 40 40
Device Dislodged or Dislocated 38 38
Premature Elective Replacement Indicator 37 37
Misconnection 33 33
Fracture 29 29
Leak/Splash 28 28
Failure to Power Up 24 24
Mechanical Problem 22 22
Material Deformation 20 20
Excessive Heating 20 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9705 9705
Pain 3703 3703
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3038 3038
Insufficient Information 2207 2207
No Known Impact Or Consequence To Patient 1936 1936
Unspecified Infection 1936 1936
Muscular Rigidity 1283 1283
Therapeutic Response, Decreased 844 844
Seroma 747 747
Cerebrospinal Fluid Leakage 656 656
Discomfort 653 653
Headache 470 470
Nausea 429 429
Inadequate Pain Relief 423 423
Swelling/ Edema 420 420
Wound Dehiscence 420 420
Malaise 383 383
Pocket Erosion 380 380
Cognitive Changes 379 379
Vomiting 335 335
Cramp(s) /Muscle Spasm(s) 334 334
Loss of consciousness 320 320
Erythema 320 320
Complaint, Ill-Defined 308 308
Ambulation Difficulties 299 299
Fluid Discharge 290 290
Therapeutic Effects, Unexpected 286 286
Fatigue 272 272
Muscle Weakness 245 245
Itching Sensation 231 231
Post Operative Wound Infection 222 222
Fever 212 212
Numbness 208 208
Bacterial Infection 206 206
Impaired Healing 188 188
Granuloma 187 187
Scar Tissue 187 187
Diaphoresis 186 186
Sleep Dysfunction 175 175
Overdose 166 166
Device Embedded In Tissue or Plaque 162 162
Purulent Discharge 158 158
Shaking/Tremors 152 152
Lethargy 139 139
Burning Sensation 136 136
Diarrhea 135 135
Convulsion/Seizure 135 135
Dizziness 134 134
Anxiety 129 129
Confusion/ Disorientation 105 105

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 Apr-01-2025
7 Medtronic Neuromodulation II Dec-27-2024
8 Medtronic Neuromodulation II Oct-21-2024
9 Medtronic Neuromodulation II Jul-12-2024
10 Medtronic Neuromodulation II Dec-22-2023
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