Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
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
2
MDR Year
MDR Reports
MDR Events
2018
6936
6936
2019
5652
5652
2020
5115
5115
2021
4713
4713
2022
4311
4311
2023
709
709
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
7418
7418
Insufficient Flow or Under Infusion
3757
3757
Infusion or Flow Problem
3349
3349
Pumping Stopped
3314
3314
Insufficient Information
3174
3174
Migration or Expulsion of Device
2829
2829
Material Integrity Problem
2354
2354
Obstruction of Flow
1950
1950
Electromagnetic Interference
1017
1017
Use of Device Problem
990
990
Improper or Incorrect Procedure or Method
960
960
Filling Problem
910
910
Fluid/Blood Leak
761
761
Device Operates Differently Than Expected
672
672
Excess Flow or Over-Infusion
670
670
Device Displays Incorrect Message
474
474
Improper Flow or Infusion
365
365
Disconnection
336
336
Volume Accuracy Problem
310
310
Aspiration Issue
308
308
Positioning Problem
292
292
Communication or Transmission Problem
284
284
Intermittent Infusion
222
222
Unstable
220
220
Failure To Service
212
212
No Audible Alarm
194
194
Human-Device Interface Problem
182
182
Patient Device Interaction Problem
171
171
Device Alarm System
164
164
Device Ingredient or Reagent Problem
160
160
Appropriate Term/Code Not Available
160
160
Failure to Disconnect
157
157
Data Problem
134
134
Inappropriate or Unexpected Reset
130
130
Battery Problem
110
110
Protective Measures Problem
108
108
Connection Problem
101
101
Kinked
100
100
Occlusion Within Device
100
100
Material Split, Cut or Torn
97
97
Migration
95
95
Premature Elective Replacement Indicator
79
79
Difficult to Advance
73
73
Failure to Interrogate
64
64
Nonstandard Device
58
58
Device Or Device Fragments Location Unknown
57
57
Inadequacy of Device Shape and/or Size
55
55
Mechanical Problem
54
54
No Flow
54
54
Application Program Problem
53
53
Material Twisted/Bent
46
46
Misconnection
44
44
Malposition of Device
39
39
Device Dislodged or Dislocated
39
39
Leak/Splash
38
38
Mechanical Jam
38
38
Ambient Temperature Problem
37
37
Material Deformation
33
33
Patient-Device Incompatibility
32
32
Fracture
30
30
Display or Visual Feedback Problem
28
28
Vibration
22
22
Unintended Electrical Shock
21
21
Suction Problem
19
19
Particulates
19
19
Retraction Problem
18
18
Material Puncture/Hole
17
17
Defective Device
17
17
Excessive Heating
17
17
Noise, Audible
17
17
Unintended Movement
17
17
Break
16
16
Device Issue
15
15
Increase in Pressure
14
14
Difficult to Interrogate
14
14
Detachment of Device or Device Component
13
13
Component Missing
12
12
Premature End-of-Life Indicator
12
12
Therapeutic or Diagnostic Output Failure
12
12
Pumping Problem
11
11
Decrease in Pressure
11
11
Contamination
9
9
Difficult to Insert
9
9
Failure to Deliver
9
9
Defective Component
9
9
Output Problem
9
9
Temperature Problem
9
9
Activation Failure
8
8
Mechanics Altered
8
8
Unexpected Therapeutic Results
8
8
Environmental Compatibility Problem
8
8
Inaccurate Delivery
7
7
Unauthorized Access to Computer System
7
7
Unexpected Shutdown
7
7
No Apparent Adverse Event
6
6
Missing Value Reason
6
6
Separation Failure
6
6
Component or Accessory Incompatibility
6
6
Computer Software Problem
6
6
Loss of Power
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
7029
7029
Pain
4594
4596
No Clinical Signs, Symptoms or Conditions
4520
4520
Therapeutic Response, Decreased
3203
3203
Unspecified Infection
2086
2087
Muscular Rigidity
1551
1552
Insufficient Information
1392
1392
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1321
1321
Complaint, Ill-Defined
1300
1300
Therapeutic Effects, Unexpected
1172
1174
Overdose
821
821
Seroma
782
782
Discomfort
773
773
Cerebrospinal Fluid Leakage
675
675
Malaise
627
627
Nausea
596
596
Cognitive Changes
515
515
Inadequate Pain Relief
494
494
Vomiting
483
483
Headache
456
456
Wound Dehiscence
421
421
Loss of consciousness
417
417
Pocket Erosion
413
414
Ambulation Difficulties
401
401
Muscle Spasm(s)
393
393
Fatigue
383
383
Erythema
364
364
Fluid Discharge
355
355
Swelling
342
342
Itching Sensation
299
299
Granuloma
292
292
No Code Available
279
279
Fever
278
278
Muscle Weakness
267
267
Numbness
248
248
Sleep Dysfunction
246
246
Shaking/Tremors
236
236
Swelling/ Edema
228
228
Post Operative Wound Infection
212
212
Bacterial Infection
208
208
Cramp(s) /Muscle Spasm(s)
206
206
Sweating
195
195
Lethargy
194
194
Burning Sensation
186
186
Diarrhea
185
185
Scar Tissue
185
185
Underdose
184
184
Impaired Healing
183
183
Dizziness
180
180
Device Embedded In Tissue or Plaque
180
180
Purulent Discharge
178
178
Anxiety
173
173
Headache, Lumbar Puncture
165
165
Irritability
157
157
Confusion/ Disorientation
155
155
Chills
155
155
Patient Problem/Medical Problem
151
151
High Blood Pressure/ Hypertension
148
148
Seizures
144
144
Weight Changes
127
128
Low Blood Pressure/ Hypotension
120
120
Meningitis
111
111
Dyspnea
110
110
Diaphoresis
107
107
Fall
106
106
Hematoma
106
106
Alteration In Body Temperature
103
103
Sepsis
101
101
Tachycardia
96
96
Convulsion/Seizure
94
94
Inflammation
89
89
Staphylococcus Aureus
87
87
Test Result
86
86
Erosion
83
83
Abdominal Pain
82
82
Hemorrhage/Bleeding
82
82
Injury
81
81
Weakness
79
79
Dysphasia
74
74
Skin Erosion
73
73
Tingling
69
69
Decreased Respiratory Rate
68
68
Distress
67
67
Bruise/Contusion
66
66
Foreign Body Reaction
64
64
Twiddlers Syndrome
62
62
Cellulitis
61
61
Emotional Changes
60
60
Abscess
59
59
Coma
59
59
Apnea
57
57
Rash
57
57
Memory Loss/Impairment
57
57
Twiddlers Syndrome
54
54
Paralysis
51
51
Bradycardia
50
50
Twitching
49
49
Electric Shock
49
49
Death
48
48
Urinary Retention
47
47
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
-
-