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TPLC
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show TPLC since
2008
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2023
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Device
pump, infusion, implanted, programmable
Product Code
LKK
Device Class
3
Premarket Approvals (PMA)
2018
2019
2020
2021
2022
2023
55
57
49
32
32
10
MDR Year
MDR Reports
MDR Events
2018
6936
6936
2019
5652
5652
2020
5115
5115
2021
4713
4713
2022
4310
4310
2023
2783
2783
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
8023
8023
Insufficient Flow or Under Infusion
3950
3950
Infusion or Flow Problem
3710
3710
Insufficient Information
3484
3484
Pumping Stopped
3413
3413
Migration or Expulsion of Device
3105
3105
Material Integrity Problem
2556
2556
Obstruction of Flow
2147
2147
Electromagnetic Interference
1115
1115
Improper or Incorrect Procedure or Method
1032
1032
Use of Device Problem
996
996
Filling Problem
981
981
Fluid/Blood Leak
814
814
Excess Flow or Over-Infusion
717
717
Device Operates Differently Than Expected
672
672
Device Displays Incorrect Message
474
474
Improper Flow or Infusion
405
405
Disconnection
375
375
Positioning Problem
324
324
Communication or Transmission Problem
312
312
Volume Accuracy Problem
310
310
Aspiration Issue
308
308
Intermittent Infusion
222
222
Unstable
220
220
Failure To Service
212
212
No Audible Alarm
200
200
Human-Device Interface Problem
191
191
Patient Device Interaction Problem
187
187
Device Ingredient or Reagent Problem
175
175
Device Alarm System
173
173
Failure to Disconnect
170
170
Appropriate Term/Code Not Available
162
162
Data Problem
148
148
Inappropriate or Unexpected Reset
134
134
Protective Measures Problem
122
122
Battery Problem
114
114
Connection Problem
104
104
Material Split, Cut or Torn
102
102
Migration
101
101
Kinked
100
100
Occlusion Within Device
100
100
Premature Elective Replacement Indicator
80
80
Difficult to Advance
78
78
Failure to Interrogate
72
72
Application Program Problem
60
60
Inadequacy of Device Shape and/or Size
60
60
Nonstandard Device
58
58
No Flow
58
58
Mechanical Problem
57
57
Device Or Device Fragments Location Unknown
57
57
Material Twisted/Bent
48
48
Misconnection
46
46
Ambient Temperature Problem
45
45
Malposition of Device
41
41
Device Dislodged or Dislocated
41
41
Leak/Splash
41
41
Mechanical Jam
38
38
Material Deformation
34
34
Patient-Device Incompatibility
33
33
Fracture
31
31
Display or Visual Feedback Problem
28
28
Vibration
24
24
Defective Device
22
22
Unintended Electrical Shock
22
22
Retraction Problem
20
20
Particulates
19
19
Suction Problem
19
19
Output Problem
19
19
Therapeutic or Diagnostic Output Failure
19
19
Noise, Audible
19
19
Unintended Movement
18
18
Break
18
18
Material Puncture/Hole
17
17
Excessive Heating
17
17
Increase in Pressure
16
16
Device Issue
15
15
Difficult to Interrogate
14
14
Detachment of Device or Device Component
14
14
Component Missing
13
13
Premature End-of-Life Indicator
12
12
Decrease in Pressure
12
12
Pumping Problem
11
11
Defective Component
10
10
Failure to Deliver
9
9
Activation, Positioning or Separation Problem
9
9
Contamination
9
9
Difficult to Insert
9
9
Temperature Problem
9
9
Unauthorized Access to Computer System
9
9
Mechanics Altered
8
8
Unexpected Shutdown
8
8
Activation Failure
8
8
Environmental Compatibility Problem
8
8
Separation Failure
8
8
Unexpected Therapeutic Results
8
8
Inaccurate Delivery
7
7
Component or Accessory Incompatibility
7
7
Material Too Rigid or Stiff
7
7
Loss of Power
6
6
Computer Software Problem
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
7029
7029
No Clinical Signs, Symptoms or Conditions
5328
5328
Pain
4935
4937
Therapeutic Response, Decreased
3203
3203
Unspecified Infection
2261
2262
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1710
1710
Muscular Rigidity
1674
1675
Insufficient Information
1614
1614
Complaint, Ill-Defined
1300
1300
Therapeutic Effects, Unexpected
1172
1174
Seroma
853
853
Discomfort
831
831
Overdose
821
821
Cerebrospinal Fluid Leakage
742
742
Malaise
659
659
Nausea
640
640
Cognitive Changes
539
539
Vomiting
521
521
Headache
514
514
Inadequate Pain Relief
513
513
Wound Dehiscence
461
461
Loss of consciousness
452
452
Pocket Erosion
445
446
Ambulation Difficulties
423
423
Fatigue
402
402
Erythema
394
394
Muscle Spasm(s)
393
393
Fluid Discharge
381
381
Swelling
342
342
Itching Sensation
317
317
Granuloma
307
307
Fever
299
299
Muscle Weakness
284
284
No Code Available
279
279
Swelling/ Edema
272
272
Numbness
265
265
Sleep Dysfunction
254
254
Shaking/Tremors
246
246
Post Operative Wound Infection
240
240
Cramp(s) /Muscle Spasm(s)
236
236
Bacterial Infection
226
226
Burning Sensation
207
207
Diarrhea
202
202
Lethargy
202
202
Impaired Healing
200
200
Scar Tissue
198
198
Sweating
195
195
Dizziness
193
193
Purulent Discharge
190
190
Device Embedded In Tissue or Plaque
188
188
Anxiety
184
184
Underdose
184
184
Irritability
166
166
Confusion/ Disorientation
165
165
Headache, Lumbar Puncture
165
165
Chills
162
162
High Blood Pressure/ Hypertension
154
154
Patient Problem/Medical Problem
151
151
Seizures
144
144
Weight Changes
137
138
Low Blood Pressure/ Hypotension
136
136
Diaphoresis
126
126
Meningitis
123
123
Dyspnea
116
116
Fall
114
114
Hematoma
113
113
Sepsis
110
110
Tachycardia
104
104
Convulsion/Seizure
104
104
Alteration In Body Temperature
103
103
Inflammation
96
96
Hemorrhage/Bleeding
92
92
Staphylococcus Aureus
87
87
Erosion
87
87
Test Result
86
86
Abdominal Pain
85
85
Dysphasia
81
81
Injury
81
81
Weakness
79
79
Skin Erosion
78
78
Foreign Body Reaction
72
72
Bruise/Contusion
71
71
Distress
71
71
Decreased Respiratory Rate
71
71
Twiddlers Syndrome
71
71
Tingling
69
69
Abscess
65
65
Rash
64
64
Cellulitis
63
63
Coma
63
63
Apnea
61
61
Emotional Changes
61
61
Memory Loss/Impairment
59
59
Alteration in Body Temperature
55
55
Bradycardia
54
54
Twiddlers Syndrome
54
54
Paralysis
53
53
Twitching
51
51
Urinary Retention
51
51
Constipation
49
49
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
Jun-03-2020
6
Medtronic Neuromodulation
I
Dec-03-2019
7
Medtronic Neuromodulation
II
Mar-03-2018
8
Medtronic Neuromodulation
III
Feb-06-2018
9
Smiths Medical ASD Inc.
II
Sep-23-2019
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