TPLC - Total Product Life Cycle

• Device: pump, infusion, implanted, programmable
• Product Code: LKK
• Device Class: 3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
57	49	32	32	19	15

MDR Year	MDR Reports	MDR Events
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	7438	7438
Infusion or Flow Problem	3953	3953
Insufficient Flow or Under Infusion	3699	3699
Insufficient Information	3536	3536
Migration or Expulsion of Device	3155	3155
Pumping Stopped	2812	2813
Material Integrity Problem	2412	2412
Obstruction of Flow	2231	2231
Electromagnetic Interference	1177	1177
Filling Problem	916	916
Improper or Incorrect Procedure or Method	906	906
Fluid/Blood Leak	777	777
Use of Device Problem	723	723
Excess Flow or Over-Infusion	655	655
Improper Flow or Infusion	442	442
Communication or Transmission Problem	381	381
Positioning Problem	330	330
Disconnection	328	328
Device Alarm System	301	302
Patient Device Interaction Problem	191	191
No Audible Alarm	161	161
Device Ingredient or Reagent Problem	161	161
Failure to Disconnect	151	151
Data Problem	145	145
Human-Device Interface Problem	137	137
Protective Measures Problem	115	115
Appropriate Term/Code Not Available	109	109
Migration	101	101
Material Split, Cut or Torn	101	101
Connection Problem	96	96
Inappropriate or Unexpected Reset	87	87
Difficult to Advance	82	82
Battery Problem	80	80
Application Program Problem	67	67
Failure to Interrogate	65	65
No Flow	64	64
Charging Problem	58	58
Inadequacy of Device Shape and/or Size	54	54
Premature Elective Replacement Indicator	50	50
Ambient Temperature Problem	47	47
Misconnection	45	45
Material Twisted/Bent	44	44
Device Dislodged or Dislocated	38	38
Leak/Splash	31	31
Mechanical Problem	30	30
Fracture	28	28
Material Deformation	25	25
Vibration	24	24
Excessive Heating	23	23
Unintended Electrical Shock	21	21

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7380	7381
No Known Impact Or Consequence To Patient	4261	4261
Pain	4164	4164
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2528	2528
Unspecified Infection	2098	2098
Insufficient Information	1984	1984
Therapeutic Response, Decreased	1857	1857
Muscular Rigidity	1475	1475
Seroma	815	815
Discomfort	753	753
Complaint, Ill-Defined	749	749
Cerebrospinal Fluid Leakage	727	727
Therapeutic Effects, Unexpected	668	668
Nausea	520	520
Malaise	504	504
Headache	490	490
Inadequate Pain Relief	479	479
Wound Dehiscence	449	449
Cognitive Changes	431	431
Overdose	425	425
Vomiting	417	417
Pocket Erosion	409	409
Loss of consciousness	384	384
Swelling/ Edema	372	372
Erythema	356	356
Ambulation Difficulties	340	340
Fluid Discharge	331	331
Fatigue	329	329
Cramp(s) /Muscle Spasm(s)	293	293
Muscle Weakness	264	264
Itching Sensation	259	259
Granuloma	255	255
Numbness	247	247
Fever	247	247
Post Operative Wound Infection	238	238
Muscle Spasm(s)	219	219
Bacterial Infection	219	219
Sleep Dysfunction	218	218
Scar Tissue	202	202
Impaired Healing	197	197
Shaking/Tremors	196	196
Device Embedded In Tissue or Plaque	188	188
Swelling	186	186
Purulent Discharge	177	177
Burning Sensation	173	173
Diarrhea	172	172
Lethargy	170	170
Dizziness	163	163
Diaphoresis	162	162
Anxiety	150	150

Recalls
Manufacturer		Recall Class	Date Posted
1	Flowonix Medical Inc	II	Jul-01-2021
2	Flowonix Medical Inc	II	Feb-10-2020
3	Flowonix Medical Inc	II	Jun-03-2019
4	Intera Oncology, Inc.	I	Aug-22-2022
5	Medtronic Inc.	II	Dec-09-2023
6	Medtronic Inc.	II	Jun-03-2020
7	Medtronic Neuromodulation	II	Jul-12-2024
8	Medtronic Neuromodulation	II	Dec-22-2023
9	Medtronic Neuromodulation	I	Dec-03-2019
10	Smiths Medical ASD Inc.	II	Sep-23-2019