TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2014	2015	2016	2017	2018	2019
27	40	30	42	55	53

Device Problems
Adverse Event Without Identified Device or Use Problem	7439
Device Operates Differently Than Expected	4021
Pumping Stopped	3359
Insufficient Flow or Under Infusion	2436
Device Displays Incorrect Message	2419
Material Integrity Problem	2115
Volume Accuracy Problem	1693
Migration or Expulsion of Device	1505
Aspiration Issue	1495
Insufficient Information	1362
Failure To Service	1214
Intermittent Infusion	1192
Unstable	1143
Improper or Incorrect Procedure or Method	1125
Infusion or Flow Problem	1004
Filling Problem	869
Electromagnetic Interference	775
Inappropriate or Unexpected Reset	763
Fluid Leak	686
Excess Flow or Over-Infusion	653
Use of Device Problem	647
Obstruction of Flow	614
Occlusion Within Device	605
Kinked	516
Disconnection	359
No Audible Alarm	338
Device Or Device Fragments Location Unknown	297
Human-Device Interface Problem	271
Device Alarm System	260
Nonstandard device	220
Premature Elective Replacement Indicator	212
Positioning Problem	201
Battery Problem	180
Device Ingredient or Reagent Problem	158
Communication or Transmission Problem	152
Failure to Disconnect	151
Data Problem	138
Protective Measures Problem	133
Mechanical Jam	128
Improper Flow or Infusion	123
Malposition of device	107
Failure to Interrogate	97
Appropriate Term/Code Not Available	95
Difficult to Advance	73
Application Program Problem	72
Connection Problem	72
Difficult to Interrogate	66
Patient Device Interaction Problem	59
Activation Failure Including Expansion Failures	54
Device Operational Issue	54
Inadequacy of Device Shape and/or Size	53
Device Issue	50
Temperature Problem	42
Torn Material	40
Premature End-of-Life Indicator	34
Misconnection	32
Vibration	31
Activation, Positioning or Separation Problem	28
Material Split, Cut or Torn	27
Catheter	27
Shelf Life Exceeded	26
No Flow	25
Increase in Pressure	20
Noise, Audible	18
Environmental Compatibility Problem	17
Material Deformation	16
Decrease in Pressure	16
Ambient Temperature Problem	16
Leak / Splash	15
Mechanical Problem	14
Material Puncture / Hole	13
Overfill	13
Unintended Electrical Shock	12
Component Missing	12
Display or Visual Feedback Problem	11
Particulates	10
Contamination During Use	9
Inadequate or Insufficient Training	8
Difficult To Position	8
Missing Value Reason	8
Pump	8
Material Too Rigid or Stiff	7
Changes In Ambient Temperature In Device Environment	7
Pumping Problem	7
Off-Label Use	7
Difficult to Insert	6
Extrusion	6
Excessive Heating	6
Device Handling Problem	6
Bent	6
Device Damaged by Another Device	6
Defective Device	6
Detachment Of Device Component	6
Low Battery	6
Unintended Movement	5
Difficult or Delayed Positioning	5
Migration	5
Separation Failure	4
Labelling, Instructions for Use or Training Problem	4
Detachment of Device or device Component	4
Total Device Problems	44488

Recalls
Manufacturer		Recall Class	Date Posted
1	Codman & Shurtleff, Inc.	II	May-28-2015
2	Codman & Shurtleff, Inc.	II	May-09-2014
3	Flowonix Medical Inc	II	Jun-03-2019
4	Flowonix Medical, Inc.	II	Jun-19-2017
5	Medtronic Neuromodulation	I	Dec-03-2019
6	Medtronic Neuromodulation	II	Mar-03-2018
7	Medtronic Neuromodulation	III	Feb-06-2018
8	Medtronic Neuromodulation	II	Mar-29-2017
9	Medtronic Neuromodulation	I	Dec-19-2016
10	Medtronic Neuromodulation	II	Mar-29-2016
11	Medtronic Neuromodulation	II	May-28-2015
12	Medtronic Neuromodulation	II	Aug-08-2014
13	Medtronic Neuromodulation	II	Jun-04-2014
14	Medtronic Neuromodulation	II	May-08-2014
15	Medtronic Neuromodulation	II	May-08-2014
16	Smiths Medical ASD Inc.	II	Sep-23-2019