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	19

MDR Year	MDR Reports	MDR Events
2020	5115	5116
2021	4713	4715
2022	4310	4313
2023	4041	4041
2024	4619	4619
2025	4977	4978

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	7406	7407
Infusion or Flow Problem	3970	3970
Insufficient Information	3484	3484
Insufficient Flow or Under Infusion	3342	3342
Migration or Expulsion of Device	3153	3153
Material Integrity Problem	2346	2347
Pumping Stopped	2298	2298
Obstruction of Flow	2205	2205
Communication or Transmission Problem	2006	2006
Electromagnetic Interference	1213	1213
Filling Problem	888	888
Improper or Incorrect Procedure or Method	830	830
Fluid/Blood Leak	754	754
Excess Flow or Over-Infusion	647	647
Device Alarm System	569	569
Improper Flow or Infusion	446	446
Application Program Problem	393	393
Positioning Problem	354	354
Use of Device Problem	352	352
Charging Problem	345	345
Disconnection	327	327
Patient Device Interaction Problem	178	178
Data Problem	177	177
Protective Measures Problem	167	167
Failure to Disconnect	152	152
No Audible Alarm	143	143
Device Ingredient or Reagent Problem	140	140
Human-Device Interface Problem	120	120
Battery Problem	112	113
Migration	99	99
Connection Problem	92	92
Material Split, Cut or Torn	87	87
Appropriate Term/Code Not Available	85	85
Difficult to Advance	83	84
Inappropriate or Unexpected Reset	81	81
Display or Visual Feedback Problem	74	74
No Flow	64	64
Failure to Interrogate	58	58
Inadequacy of Device Shape and/or Size	56	56
Failure to Power Up	50	50
Material Twisted/Bent	49	49
Ambient Temperature Problem	40	40
Device Dislodged or Dislocated	38	38
Premature Elective Replacement Indicator	38	38
Misconnection	35	35
Leak/Splash	29	29
Fracture	29	29
Mechanical Problem	24	24
Unintended Electrical Shock	23	23
Excessive Heating	21	21

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	11415	11416
Pain	3973	3977
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3362	3362
Insufficient Information	2361	2361
Unspecified Infection	2103	2103
No Known Impact Or Consequence To Patient	1936	1936
Muscular Rigidity	1353	1353
Therapeutic Response, Decreased	844	844
Seroma	791	791
Cerebrospinal Fluid Leakage	711	711
Discomfort	699	699
Headache	505	505
Swelling/ Edema	459	459
Nausea	457	457
Wound Dehiscence	454	454
Inadequate Pain Relief	424	424
Pocket Erosion	405	405
Malaise	404	404
Cognitive Changes	398	398
Cramp(s) /Muscle Spasm(s)	357	360
Vomiting	355	355
Erythema	345	345
Loss of consciousness	343	343
Ambulation Difficulties	320	320
Complaint, Ill-Defined	308	308
Fluid Discharge	305	305
Fatigue	287	287
Therapeutic Effects, Unexpected	286	286
Muscle Weakness	264	264
Itching Sensation	242	242
Post Operative Wound Infection	238	238
Fever	224	224
Bacterial Infection	218	218
Numbness	213	213
Impaired Healing	204	204
Granuloma	199	199
Scar Tissue	197	197
Diaphoresis	195	195
Sleep Dysfunction	186	187
Purulent Discharge	174	174
Device Embedded In Tissue or Plaque	173	173
Overdose	166	166
Shaking/Tremors	160	160
Burning Sensation	148	148
Lethargy	144	144
Convulsion/Seizure	142	142
Diarrhea	141	141
Dizziness	139	139
Anxiety	137	137
Confusion/ Disorientation	112	112

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