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	16

MDR Year	MDR Reports	MDR Events
2019	5652	5652
2020	5115	5115
2021	4713	4713
2022	4310	4310
2023	4042	4042
2024	3472	3472

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	7542	7542
Infusion or Flow Problem	4019	4019
Insufficient Flow or Under Infusion	3735	3735
Insufficient Information	3583	3583
Migration or Expulsion of Device	3211	3211
Pumping Stopped	2831	2832
Material Integrity Problem	2455	2455
Obstruction of Flow	2263	2263
Electromagnetic Interference	1204	1204
Filling Problem	928	928
Improper or Incorrect Procedure or Method	912	912
Fluid/Blood Leak	791	791
Use of Device Problem	724	724
Excess Flow or Over-Infusion	666	666
Improper Flow or Infusion	448	448
Communication or Transmission Problem	399	399
Device Alarm System	343	344
Positioning Problem	334	334
Disconnection	332	332
Patient Device Interaction Problem	192	192
Device Ingredient or Reagent Problem	163	163
No Audible Alarm	162	162
Failure to Disconnect	156	156
Data Problem	145	145
Human-Device Interface Problem	139	139
Protective Measures Problem	119	119
Appropriate Term/Code Not Available	109	109
Migration	102	102
Material Split, Cut or Torn	101	101
Connection Problem	97	97
Inappropriate or Unexpected Reset	88	88
Difficult to Advance	84	84
Battery Problem	81	81
Charging Problem	67	67
Application Program Problem	67	67
No Flow	66	66
Failure to Interrogate	66	66
Inadequacy of Device Shape and/or Size	55	55
Premature Elective Replacement Indicator	50	50
Ambient Temperature Problem	48	48
Misconnection	46	46
Material Twisted/Bent	44	44
Device Dislodged or Dislocated	38	38
Leak/Splash	31	31
Mechanical Problem	30	30
Fracture	28	28
Vibration	25	25
Material Deformation	25	25
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	7577	7578
No Known Impact Or Consequence To Patient	4261	4261
Pain	4213	4213
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2603	2603
Unspecified Infection	2136	2136
Insufficient Information	2017	2017
Therapeutic Response, Decreased	1857	1857
Muscular Rigidity	1492	1492
Seroma	830	830
Discomfort	761	761
Complaint, Ill-Defined	749	749
Cerebrospinal Fluid Leakage	736	736
Therapeutic Effects, Unexpected	668	668
Nausea	525	525
Malaise	508	508
Headache	496	496
Inadequate Pain Relief	479	479
Wound Dehiscence	456	456
Cognitive Changes	440	440
Overdose	425	425
Vomiting	419	419
Pocket Erosion	414	414
Loss of consciousness	385	385
Swelling/ Edema	378	378
Erythema	361	361
Ambulation Difficulties	344	344
Fluid Discharge	333	333
Fatigue	330	330
Cramp(s) /Muscle Spasm(s)	298	298
Muscle Weakness	268	268
Itching Sensation	262	262
Granuloma	255	255
Fever	250	250
Numbness	248	248
Post Operative Wound Infection	242	242
Bacterial Infection	225	225
Sleep Dysfunction	219	219
Muscle Spasm(s)	219	219
Scar Tissue	206	206
Impaired Healing	199	199
Shaking/Tremors	196	196
Device Embedded In Tissue or Plaque	189	189
Swelling	186	186
Purulent Discharge	182	182
Burning Sensation	175	175
Lethargy	172	172
Diarrhea	172	172
Diaphoresis	164	164
Dizziness	163	163
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