TPLC - Total Product Life Cycle

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