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TPLC
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show TPLC since
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2020
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2025
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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
2
MDR Year
MDR Reports
MDR Events
2020
5115
5115
2021
4713
4713
2022
4310
4310
2023
4042
4042
2024
4619
4619
2025
367
367
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
6431
6431
Infusion or Flow Problem
3543
3543
Insufficient Information
2999
2999
Insufficient Flow or Under Infusion
2966
2966
Migration or Expulsion of Device
2818
2818
Pumping Stopped
2112
2113
Material Integrity Problem
2077
2077
Obstruction of Flow
1965
1965
Electromagnetic Interference
1040
1040
Filling Problem
775
775
Improper or Incorrect Procedure or Method
749
749
Fluid/Blood Leak
674
674
Excess Flow or Over-Infusion
553
553
Communication or Transmission Problem
486
486
Device Alarm System
411
412
Improper Flow or Infusion
384
384
Use of Device Problem
345
345
Disconnection
289
289
Positioning Problem
288
288
Charging Problem
157
157
Patient Device Interaction Problem
156
156
Data Problem
145
145
No Audible Alarm
130
130
Failure to Disconnect
129
129
Device Ingredient or Reagent Problem
128
128
Application Program Problem
103
103
Protective Measures Problem
101
101
Human-Device Interface Problem
99
99
Migration
97
97
Material Split, Cut or Torn
83
83
Battery Problem
79
79
Connection Problem
78
78
Appropriate Term/Code Not Available
76
76
Inappropriate or Unexpected Reset
74
74
Difficult to Advance
64
64
Failure to Interrogate
57
57
Inadequacy of Device Shape and/or Size
54
54
No Flow
52
52
Material Twisted/Bent
42
42
Device Dislodged or Dislocated
38
38
Ambient Temperature Problem
38
38
Premature Elective Replacement Indicator
36
36
Misconnection
31
31
Fracture
28
28
Leak/Splash
27
27
Mechanical Problem
22
22
Display or Visual Feedback Problem
21
21
Material Deformation
19
19
Excessive Heating
19
19
Vibration
19
19
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
8374
8375
Pain
3505
3505
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2793
2793
Insufficient Information
2104
2104
No Known Impact Or Consequence To Patient
1936
1936
Unspecified Infection
1811
1811
Muscular Rigidity
1214
1214
Therapeutic Response, Decreased
844
844
Seroma
714
714
Discomfort
632
632
Cerebrospinal Fluid Leakage
626
626
Headache
447
447
Inadequate Pain Relief
422
422
Nausea
407
407
Swelling/ Edema
400
400
Wound Dehiscence
394
394
Malaise
364
364
Pocket Erosion
359
359
Cognitive Changes
357
357
Vomiting
321
321
Cramp(s) /Muscle Spasm(s)
315
315
Complaint, Ill-Defined
308
308
Erythema
305
305
Loss of consciousness
300
300
Therapeutic Effects, Unexpected
286
286
Ambulation Difficulties
281
281
Fluid Discharge
269
269
Fatigue
263
263
Muscle Weakness
233
233
Itching Sensation
214
214
Post Operative Wound Infection
212
212
Fever
200
200
Numbness
197
197
Bacterial Infection
195
195
Impaired Healing
180
180
Granuloma
180
180
Scar Tissue
176
176
Diaphoresis
171
171
Sleep Dysfunction
170
170
Overdose
166
166
Device Embedded In Tissue or Plaque
156
156
Purulent Discharge
151
151
Shaking/Tremors
145
145
Lethargy
135
135
Diarrhea
131
131
Convulsion/Seizure
129
129
Anxiety
128
128
Burning Sensation
127
127
Dizziness
126
126
Confusion/ Disorientation
102
102
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
Dec-27-2024
7
Medtronic Neuromodulation
II
Oct-21-2024
8
Medtronic Neuromodulation
II
Jul-12-2024
9
Medtronic Neuromodulation
II
Dec-22-2023
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