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TPLC
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Device
stimulator, autonomic nerve, implanted for epilepsy
Product Code
LYJ
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
6
1
3
5
3
0
MDR Year
MDR Reports
MDR Events
2020
1688
1688
2021
1764
1764
2022
1584
1584
2023
1764
1764
2024
1525
1581
2025
99
99
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
4527
4576
Fracture
1872
1879
High impedance
961
968
Low impedance
249
249
Naturally Worn
222
222
Premature Discharge of Battery
222
222
Device Contamination with Body Fluid
191
191
Corroded
115
115
Electrical Shorting
110
110
Inappropriate or Unexpected Reset
90
90
Physical Resistance/Sticking
88
88
False Alarm
88
88
Failure to Deliver Energy
80
80
Insufficient Information
79
86
Incomplete or Inadequate Connection
79
79
Premature End-of-Life Indicator
79
79
Output below Specifications
69
69
Failure to Interrogate
68
68
Energy Output Problem
65
65
Computer Software Problem
60
60
Detachment of Device or Device Component
59
59
Therapeutic or Diagnostic Output Failure
53
53
Mechanical Problem
40
40
Incorrect, Inadequate or Imprecise Result or Readings
37
37
Device Contaminated During Manufacture or Shipping
33
33
Material Twisted/Bent
31
31
Therapy Delivered to Incorrect Body Area
31
31
Application Program Problem: Parameter Calculation Error
30
30
Defective Component
27
27
No Apparent Adverse Event
21
21
Electro-Static Discharge
16
16
Premature Elective Replacement Indicator
12
12
Communication or Transmission Problem
11
11
Migration
10
10
Battery Problem: High Impedance
10
10
Erratic or Intermittent Display
6
6
Over-Sensing
6
6
Protective Measures Problem
4
4
Break
3
3
Application Program Problem: Dose Calculation Error
3
3
Nonstandard Device
2
2
Defective Device
2
2
No Display/Image
2
2
Appropriate Term/Code Not Available
2
2
Device-Device Incompatibility
1
1
Scratched Material
1
1
Computer Operating System Problem
1
1
Failure to Deliver Shock/Stimulation
1
1
Unintended Electrical Shock
1
1
Device Displays Incorrect Message
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2826
2833
Convulsion, Clonic
1617
1617
No Known Impact Or Consequence To Patient
706
706
Seizures
496
496
Post Operative Wound Infection
424
473
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
407
407
Implant Pain
265
265
Discomfort
230
230
Neck Pain
194
194
Paralysis
185
234
Unspecified Infection
172
172
Chest Pain
155
155
Pocket Erosion
136
136
No Code Available
135
135
Insufficient Information
118
118
Wound Dehiscence
107
107
Pain
105
105
Dyspnea
103
103
Skin Infection
101
101
Apnea
96
96
Bradycardia
95
95
Status Epilepticus
83
83
Dysphagia/ Odynophagia
80
80
Vomiting
69
69
Death
61
61
Arrhythmia
52
52
Sleep Dysfunction
51
51
Paresis
50
99
Unspecified Mental, Emotional or Behavioural Problem
50
50
Cough
50
50
Headache
48
48
Shock from Patient Lead(s)
41
41
Cramp(s) /Muscle Spasm(s)
38
38
Syncope/Fainting
35
35
Ambulation Difficulties
34
34
Impaired Healing
33
33
Hemorrhage/Bleeding
32
32
Tissue Breakdown
32
32
Nerve Damage
32
32
Ecchymosis
31
31
Tachycardia
31
31
Asystole
31
31
Weight Changes
30
30
Nausea
30
30
Unspecified Heart Problem
29
29
Depression
27
27
Aspiration/Inhalation
26
26
Fibrosis
26
26
Inflammation
26
26
Unspecified Respiratory Problem
23
23
Recalls
Manufacturer
Recall Class
Date Posted
1
LivaNova USA Inc
II
Dec-04-2020
2
LivaNova USA Inc
II
Nov-17-2020
3
LivaNova USA Inc
II
Mar-24-2020
4
LivaNova USA Inc
II
Feb-10-2020
5
LivaNova USA Inc
II
Jan-27-2020
6
LivaNova USA, Inc.
II
Jan-31-2025
7
LivaNova USA, Inc.
II
Jan-30-2025
8
LivaNova USA, Inc.
II
Jan-28-2022
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