TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
32	32	19	22	22	5

MDR Year	MDR Reports	MDR Events
2021	4713	4715
2022	4310	4313
2023	4041	4041
2024	4619	4619
2025	5816	5817
2026	2057	2057

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	6621	6622
Infusion or Flow Problem	3527	3527
Communication or Transmission Problem	3328	3328
Insufficient Information	3143	3143
Migration or Expulsion of Device	2740	2740
Insufficient Flow or Under Infusion	2617	2617
Material Integrity Problem	2036	2037
Obstruction of Flow	1884	1884
Pumping Stopped	1654	1654
Electromagnetic Interference	1118	1118
Filling Problem	745	745
Improper or Incorrect Procedure or Method	705	705
Fluid/Blood Leak	632	632
Application Program Problem	599	599
Device Alarm System	596	596
Excess Flow or Over-Infusion	551	551
Charging Problem	454	454
Improper Flow or Infusion	411	411
Positioning Problem	318	318
Disconnection	282	282
Protective Measures Problem	196	196
Data Problem	165	165
Patient Device Interaction Problem	147	147
Failure to Disconnect	131	131
Device Ingredient or Reagent Problem	120	120
Battery Problem	112	112
No Audible Alarm	112	112
Human-Device Interface Problem	101	101
Display or Visual Feedback Problem	94	94
Migration	87	87
Connection Problem	81	81
Appropriate Term/Code Not Available	70	70
Failure to Power Up	69	69
Difficult to Advance	69	70
Inappropriate or Unexpected Reset	67	67
Material Split, Cut or Torn	63	63
No Flow	61	61
Use of Device Problem	52	52
Material Twisted/Bent	50	50
Failure to Interrogate	49	49
Inadequacy of Device Shape and/or Size	44	44
Device Dislodged or Dislocated	35	35
Ambient Temperature Problem	32	32
Fracture	29	29
Misconnection	29	29
Mechanical Problem	24	24
Retraction Problem	23	23
Leak/Splash	22	22
Premature Elective Replacement Indicator	21	21
Unintended Electrical Shock	21	21

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	13059	13060
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3457	3457
Pain	3389	3393
Insufficient Information	2378	2378
Unspecified Infection	1867	1867
Muscular Rigidity	1107	1107
Seroma	698	698
Cerebrospinal Fluid Leakage	650	650
Discomfort	597	597
Headache	474	474
Swelling/ Edema	447	447
Nausea	384	384
Wound Dehiscence	383	383
Cramp(s) /Muscle Spasm(s)	353	356
Inadequate Pain Relief	338	338
Pocket Erosion	332	332
Cognitive Changes	326	326
Malaise	314	314
Erythema	299	299
Vomiting	285	285
Loss of consciousness	280	280
Ambulation Difficulties	260	260
Fluid Discharge	250	250
Muscle Weakness	235	235
Fatigue	226	226
Bacterial Infection	204	204
Post Operative Wound Infection	200	200
Itching Sensation	192	192
Diaphoresis	188	188
Fever	185	185
Impaired Healing	178	178
Numbness	168	168
Scar Tissue	166	166
Purulent Discharge	151	151
Sleep Dysfunction	149	149
Device Embedded In Tissue or Plaque	148	148
Granuloma	142	142
Convulsion/Seizure	134	134
Shaking/Tremors	125	125
Burning Sensation	121	121
Lethargy	121	121
Diarrhea	121	121
Dizziness	113	113
Alteration in Body Temperature	104	104
Confusion/ Disorientation	99	99
Anxiety	96	96
Hemorrhage/Bleeding	96	96
Twiddlers Syndrome	95	95
Meningitis	90	90
High Blood Pressure/ Hypertension	89	89

Recalls
Manufacturer		Recall Class	Date Posted
1	Flowonix Medical Inc	II	Jul-01-2021
2	Intera Oncology, Inc.	I	Aug-22-2022
3	Medtronic Inc.	II	Dec-09-2023
4	Medtronic Neuromodulation	II	Apr-01-2025
5	Medtronic Neuromodulation	II	Dec-27-2024
6	Medtronic Neuromodulation	II	Oct-21-2024
7	Medtronic Neuromodulation	II	Jul-12-2024
8	Medtronic Neuromodulation	II	Dec-22-2023