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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
38
MDR Year
MDR Reports
MDR Events
2018
23626
23626
2019
30039
30039
2020
28106
28106
2021
24330
24330
2022
23271
23271
2023
20636
20636
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
37445
37445
Charging Problem
17941
17941
Battery Problem
14575
14575
High impedance
14528
14528
Insufficient Information
12491
12491
Migration
11979
11979
Unexpected Therapeutic Results
8755
8755
Therapeutic or Diagnostic Output Failure
8582
8582
Wireless Communication Problem
7381
7381
Improper or Incorrect Procedure or Method
5823
5823
Overheating of Device
5818
5818
Communication or Transmission Problem
5759
5759
Failure to Deliver Energy
5557
5557
Migration or Expulsion of Device
5143
5143
Inappropriate/Inadequate Shock/Stimulation
4341
4341
Energy Output Problem
4048
4048
Failure to Interrogate
3351
3351
Fracture
3081
3081
Unintended Collision
3071
3071
Delayed Charge Time
3038
3038
Premature Elective Replacement Indicator
2990
2990
Use of Device Problem
2586
2586
Impedance Problem
2427
2427
Device Operates Differently Than Expected
2113
2113
Patient Device Interaction Problem
2047
2047
Intermittent Continuity
1838
1838
Break
1810
1810
No Device Output
1704
1704
Connection Problem
1642
1642
Premature Discharge of Battery
1640
1640
Therapy Delivered to Incorrect Body Area
1474
1474
Malposition of Device
1403
1403
Defective Device
1290
1290
Low impedance
1089
1089
Electromagnetic Compatibility Problem
1025
1025
Positioning Problem
944
944
Device Displays Incorrect Message
898
898
Display or Visual Feedback Problem
872
872
Unstable
862
862
Electromagnetic Interference
698
698
Application Program Freezes, Becomes Nonfunctional
660
660
Data Problem
626
626
Disconnection
591
591
Patient-Device Incompatibility
532
532
No Apparent Adverse Event
510
510
Low Battery
495
495
Application Program Problem
487
487
Material Integrity Problem
459
459
Device Inoperable
393
393
Failure to Charge
360
360
Material Frayed
300
300
Temperature Problem
272
272
Device Dislodged or Dislocated
240
240
Pocket Stimulation
215
215
Appropriate Term/Code Not Available
200
200
Material Deformation
190
190
Loss of Data
190
190
Failure to Power Up
190
190
Difficult to Remove
189
189
Device Difficult to Program or Calibrate
164
164
Premature End-of-Life Indicator
153
153
Operating System Becomes Nonfunctional
150
150
Material Twisted/Bent
144
144
Intermittent Energy Output
140
140
Material Fragmentation
134
134
Computer Software Problem
134
134
Difficult to Insert
123
123
Human-Device Interface Problem
111
111
Unexpected Shutdown
110
110
Material Split, Cut or Torn
105
105
Environmental Compatibility Problem
99
99
Shipping Damage or Problem
97
97
Device Or Device Fragments Location Unknown
96
96
Device Contamination with Chemical or Other Material
89
89
Detachment of Device or Device Component
81
81
Energy Output To Patient Tissue Incorrect
79
79
Degraded
69
69
Audible Prompt/Feedback Problem
66
66
Power Problem
64
64
Unintended Movement
60
60
Inadequacy of Device Shape and/or Size
55
55
Unable to Obtain Readings
52
52
Material Separation
49
49
Material Protrusion/Extrusion
48
48
Device Damaged by Another Device
46
46
Mechanical Problem
44
44
Loss of Power
43
43
Output Problem
40
40
Failure to Disconnect
37
37
Improper Device Output
35
35
Electro-Static Discharge
33
33
Vibration
31
31
Component Missing
29
29
Failure to Fire
29
29
Entrapment of Device
28
28
Noise, Audible
27
27
Failure to Advance
23
23
Ambient Noise Problem
21
21
Structural Problem
20
20
Inadequate Instructions for Non-Healthcare Professional
20
20
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Inadequate Pain Relief
50583
50583
No Clinical Signs, Symptoms or Conditions
21801
21801
Pain
17489
17492
No Known Impact Or Consequence To Patient
13548
13550
No Code Available
12222
12222
Therapeutic Effects, Unexpected
7399
7405
Discomfort
6361
6361
Unspecified Infection
5463
5464
No Consequences Or Impact To Patient
5078
5079
Insufficient Information
4001
4001
Undesired Nerve Stimulation
3662
3662
Implant Pain
3426
3426
Burning Sensation
3289
3289
Electric Shock
3218
3218
Failure of Implant
2660
2660
Therapeutic Response, Decreased
2336
2337
Complaint, Ill-Defined
2135
2136
Post Operative Wound Infection
1988
1988
Bacterial Infection
1378
1378
Device Overstimulation of Tissue
1320
1320
Wound Dehiscence
998
998
Ambulation Difficulties
983
983
Fluid Discharge
980
980
Cerebrospinal Fluid Leakage
945
945
Numbness
935
935
Erosion
877
877
Fall
835
835
Hematoma
827
827
Headache
715
715
Swelling
650
650
Impaired Healing
635
635
Scar Tissue
541
542
Burn(s)
523
523
Fever
510
510
Paralysis
503
503
Swelling/ Edema
501
501
Muscle Weakness
497
497
Death
437
437
Erythema
428
428
Weight Changes
381
381
Purulent Discharge
379
379
No Information
377
377
Pocket Erosion
365
365
Hypersensitivity/Allergic reaction
351
351
Sleep Dysfunction
344
344
Tingling
328
328
Seroma
312
312
Muscle Spasm(s)
291
291
Nausea
290
290
Device Embedded In Tissue or Plaque
285
285
Staphylococcus Aureus
264
264
Inflammation
263
263
Irritation
238
238
Skin Inflammation/ Irritation
224
224
Cramp(s) /Muscle Spasm(s)
223
223
Paresthesia
219
219
Bruise/Contusion
219
219
Weakness
219
219
Itching Sensation
212
212
Hemorrhage/Bleeding
210
210
Abdominal Pain
206
206
Abscess
186
186
Skin Erosion
170
170
Vomiting
166
166
Stroke/CVA
161
161
Rash
160
160
Anxiety
147
147
Nerve Damage
143
143
Incontinence
140
140
Neurological Deficit/Dysfunction
138
138
Sepsis
135
135
Shaking/Tremors
123
123
Malaise
122
122
Dizziness
116
116
Headache, Lumbar Puncture
115
115
Dyspnea
115
115
Seizures
113
113
Alteration In Body Temperature
109
109
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
104
104
Chest Pain
102
102
Neck Pain
100
100
Neuropathy
98
98
Cognitive Changes
93
93
Muscular Rigidity
88
88
Distress
85
85
Cramp(s)
82
82
Urinary Retention
81
82
Myocardial Infarction
78
78
High Blood Pressure/ Hypertension
72
72
Foreign Body Reaction
71
71
Foreign Body In Patient
69
69
Discharge
68
68
Chills
67
67
Spinal Cord Injury
67
67
Convulsion/Seizure
67
67
Cardiac Arrest
66
66
Pneumonia
63
63
Fatigue
61
61
Loss of consciousness
60
60
Cellulitis
59
59
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Medical
I
Sep-11-2023
2
Boston Scientific Neuromodulation Corporation
II
May-26-2020
3
Medtronic Neuromodulation
II
Jul-21-2023
4
Medtronic Neuromodulation
II
Jun-29-2023
5
Medtronic Neuromodulation
II
Jan-06-2023
6
Medtronic Neuromodulation
II
Aug-25-2022
7
Medtronic Neuromodulation
II
Aug-24-2022
8
Medtronic Neuromodulation
II
May-23-2022
9
Medtronic Neuromodulation
II
Nov-24-2021
10
Medtronic Neuromodulation
II
Jul-28-2021
11
Medtronic Neuromodulation
II
May-06-2021
12
Medtronic Neuromodulation
II
Jan-14-2021
13
Medtronic Neuromodulation
II
Jul-13-2018
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