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TPLC
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Device
stimulator, spinal-cord, totally implanted for pain relief
Product Code
LGW
Device Class
3
Premarket Approvals (PMA)
2018
2019
2020
2021
2022
2023
64
69
52
56
60
4
MDR Year
MDR Reports
MDR Events
2018
23625
23625
2019
30039
30039
2020
28105
28105
2021
24336
24336
2022
23279
23279
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
33386
33386
Charging Problem
13895
13895
High impedance
12662
12662
Battery Problem
11796
11796
Insufficient Information
10280
10280
Migration
10156
10156
Therapeutic or Diagnostic Output Failure
7923
7923
Unexpected Therapeutic Results
7548
7548
Wireless Communication Problem
6035
6035
Improper or Incorrect Procedure or Method
5379
5379
Failure to Deliver Energy
4959
4959
Migration or Expulsion of Device
4492
4492
Communication or Transmission Problem
3948
3948
Inappropriate/Inadequate Shock/Stimulation
3700
3700
Energy Output Problem
3685
3685
Premature Elective Replacement Indicator
2986
2986
Unintended Collision
2857
2857
Fracture
2645
2645
Use of Device Problem
2469
2469
Failure to Interrogate
2308
2308
Delayed Charge Time
2273
2273
Impedance Problem
2185
2185
Device Operates Differently Than Expected
2113
2113
Overheating of Device
1917
1917
Patient Device Interaction Problem
1863
1863
Intermittent Continuity
1702
1702
No Device Output
1665
1665
Break
1551
1551
Premature Discharge of Battery
1533
1533
Therapy Delivered to Incorrect Body Area
1325
1325
Malposition of Device
1264
1264
Defective Device
1118
1118
Low impedance
1024
1024
Electromagnetic Compatibility Problem
937
937
Connection Problem
887
887
Device Displays Incorrect Message
885
885
Positioning Problem
831
831
Unstable
764
764
Application Program Freezes, Becomes Nonfunctional
660
660
Electromagnetic Interference
641
641
Disconnection
546
546
Data Problem
534
534
Patient-Device Incompatibility
510
510
Display or Visual Feedback Problem
508
508
Low Battery
495
495
No Apparent Adverse Event
439
439
Material Integrity Problem
439
439
Device Inoperable
393
393
Failure to Charge
342
342
Application Program Problem
327
327
Temperature Problem
263
263
Device Dislodged or Dislocated
208
208
Pocket Stimulation
189
189
Appropriate Term/Code Not Available
182
182
Failure to Power Up
168
168
Difficult to Remove
161
161
Loss of Data
161
161
Material Deformation
159
159
Premature End-of-Life Indicator
153
153
Device Difficult to Program or Calibrate
153
153
Material Twisted/Bent
129
129
Intermittent Energy Output
121
121
Material Fragmentation
118
118
Difficult to Insert
110
110
Human-Device Interface Problem
103
103
Unexpected Shutdown
103
103
Material Split, Cut or Torn
100
100
Device Or Device Fragments Location Unknown
96
96
Shipping Damage or Problem
93
93
Environmental Compatibility Problem
85
85
Energy Output To Patient Tissue Incorrect
79
79
Detachment of Device or Device Component
73
73
Device Contamination with Chemical or Other Material
71
71
Material Frayed
65
65
Unintended Movement
54
54
Power Problem
53
53
Degraded
53
53
Unable to Obtain Readings
52
52
Inadequacy of Device Shape and/or Size
51
51
Material Separation
48
48
Material Protrusion/Extrusion
45
45
Device Damaged by Another Device
44
44
Loss of Power
41
41
Mechanical Problem
40
40
Improper Device Output
35
35
Failure to Disconnect
30
30
Electro-Static Discharge
29
29
Failure to Fire
29
29
Operating System Becomes Nonfunctional
27
27
Computer Software Problem
27
27
Component Missing
27
27
Vibration
26
26
Noise, Audible
25
25
Output Problem
22
22
Entrapment of Device
21
21
Ambient Noise Problem
19
19
Inadequate Instructions for Non-Healthcare Professional
19
19
Telemetry Discrepancy
19
19
Device Stops Intermittently
18
18
Failure to Advance
18
18
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Inadequate Pain Relief
44433
44433
Pain
15066
15069
No Clinical Signs, Symptoms or Conditions
14216
14216
No Known Impact Or Consequence To Patient
13548
13550
No Code Available
12222
12222
Therapeutic Effects, Unexpected
7399
7405
Discomfort
5838
5838
No Consequences Or Impact To Patient
5077
5078
Unspecified Infection
4880
4881
Undesired Nerve Stimulation
3250
3250
Insufficient Information
2874
2874
Electric Shock
2752
2752
Therapeutic Response, Decreased
2336
2337
Burning Sensation
2333
2333
Implant Pain
2298
2298
Complaint, Ill-Defined
2135
2136
Post Operative Wound Infection
1726
1726
Failure of Implant
1721
1721
Device Overstimulation of Tissue
1235
1235
Bacterial Infection
1192
1192
Wound Dehiscence
879
879
Cerebrospinal Fluid Leakage
861
861
Ambulation Difficulties
861
861
Fluid Discharge
860
860
Numbness
822
822
Erosion
785
785
Fall
771
771
Hematoma
735
735
Swelling
650
650
Headache
638
638
Impaired Healing
559
559
Scar Tissue
481
482
Burn(s)
465
465
Fever
452
452
Paralysis
443
443
Death
437
437
Muscle Weakness
414
414
No Information
377
377
Swelling/ Edema
367
367
Weight Changes
364
364
Erythema
363
363
Purulent Discharge
337
337
Tingling
328
328
Sleep Dysfunction
319
319
Pocket Erosion
306
306
Hypersensitivity/Allergic reaction
298
298
Muscle Spasm(s)
291
291
Seroma
282
282
Staphylococcus Aureus
264
264
Device Embedded In Tissue or Plaque
254
254
Nausea
252
252
Irritation
238
238
Inflammation
234
234
Weakness
219
219
Bruise/Contusion
198
198
Abdominal Pain
183
183
Itching Sensation
183
183
Cramp(s) /Muscle Spasm(s)
179
179
Hemorrhage/Bleeding
173
173
Skin Inflammation/ Irritation
169
169
Abscess
163
163
Skin Erosion
155
155
Paresthesia
151
151
Rash
145
145
Stroke/CVA
142
142
Vomiting
140
140
Neurological Deficit/Dysfunction
138
138
Anxiety
133
133
Nerve Damage
127
127
Incontinence
124
124
Headache, Lumbar Puncture
115
115
Seizures
113
113
Alteration In Body Temperature
109
109
Shaking/Tremors
109
109
Malaise
109
109
Dyspnea
104
104
Sepsis
103
103
Dizziness
96
96
Chest Pain
90
90
Neuropathy
90
90
Neck Pain
86
86
Cognitive Changes
84
84
Muscular Rigidity
84
84
Cramp(s)
82
82
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
80
80
Distress
78
78
Urinary Retention
75
76
Foreign Body Reaction
69
69
Discharge
68
68
High Blood Pressure/ Hypertension
64
64
Spinal Cord Injury
62
62
Chills
57
57
Convulsion/Seizure
57
57
Loss of consciousness
56
56
Cardiac Arrest
56
56
Pneumonia
55
55
Cellulitis
55
55
Myocardial Infarction
55
55
Skin Irritation
53
53
Injury
51
51
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Neuromodulation Corporation
II
May-26-2020
2
Medtronic Neuromodulation
II
Jan-06-2023
3
Medtronic Neuromodulation
II
Aug-25-2022
4
Medtronic Neuromodulation
II
Aug-24-2022
5
Medtronic Neuromodulation
II
May-23-2022
6
Medtronic Neuromodulation
II
Nov-24-2021
7
Medtronic Neuromodulation
II
Jul-28-2021
8
Medtronic Neuromodulation
II
May-06-2021
9
Medtronic Neuromodulation
II
Jan-14-2021
10
Medtronic Neuromodulation
II
Jul-13-2018
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