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TPLC
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show TPLC since
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Device
stimulator, spinal-cord, totally implanted for pain relief
Product Code
LGW
Device Class
3
Premarket Approvals (PMA)
2017
2018
2019
2020
2021
2022
94
64
69
52
56
36
MDR Year
MDR Reports
MDR Events
2017
18606
18606
2018
23625
23625
2019
30039
30039
2020
28105
28105
2021
24336
24336
2022
12856
12856
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
36186
36186
Charging Problem
15931
15931
High impedance
12644
12644
Battery Problem
11858
11858
Insufficient Information
9897
9897
Migration
9079
9079
Therapeutic or Diagnostic Output Failure
7492
7492
Unexpected Therapeutic Results
6766
6766
Failure to Deliver Energy
6336
6336
Device Operates Differently Than Expected
5734
5734
Improper or Incorrect Procedure or Method
5679
5679
Migration or Expulsion of Device
5439
5439
Communication or Transmission Problem
5396
5396
Wireless Communication Problem
5298
5298
Inappropriate/Inadequate Shock/Stimulation
4113
4113
Premature Elective Replacement Indicator
3633
3633
Energy Output Problem
3577
3577
Use of Device Problem
3554
3554
Unintended Collision
3479
3479
Failure to Interrogate
2900
2900
Delayed Charge Time
2625
2625
Fracture
2486
2486
Impedance Problem
2227
2227
Device Displays Incorrect Message
2216
2216
No Device Output
2189
2189
Overheating of Device
2101
2101
Intermittent Continuity
2061
2061
Break
1799
1799
Patient Device Interaction Problem
1782
1782
Therapy Delivered to Incorrect Body Area
1723
1723
Malposition of Device
1615
1615
Premature Discharge of Battery
1575
1575
Low Battery
1341
1341
Device Inoperable
1326
1326
Connection Problem
1156
1156
Electromagnetic Compatibility Problem
1136
1136
Low impedance
1064
1064
Defective Device
1006
1006
Positioning Problem
993
993
Unstable
954
954
Electromagnetic Interference
763
763
Material Integrity Problem
675
675
Application Program Freezes, Becomes Nonfunctional
660
660
Disconnection
591
591
Failure to Charge
579
579
Display or Visual Feedback Problem
548
548
No Apparent Adverse Event
524
524
Patient-Device Incompatibility
503
503
Data Problem
489
489
Temperature Problem
272
272
Pocket Stimulation
235
235
Application Program Problem
233
233
Material Deformation
223
223
Energy Output To Patient Tissue Incorrect
215
215
Device Or Device Fragments Location Unknown
209
209
Device Dislodged or Dislocated
203
203
Failure to Power Up
194
194
Loss of Data
190
190
Appropriate Term/Code Not Available
184
184
Device Difficult to Program or Calibrate
180
180
Difficult to Remove
170
170
Premature End-of-Life Indicator
169
169
Shipping Damage or Problem
137
137
Improper Device Output
128
128
Difficult to Insert
125
125
Material Twisted/Bent
121
121
Human-Device Interface Problem
117
117
Environmental Compatibility Problem
116
116
Intermittent Energy Output
112
112
Nonstandard Device
107
107
Material Fragmentation
101
101
Unexpected Shutdown
94
94
Device Contamination with Chemical or Other Material
91
91
Material Split, Cut or Torn
86
86
Material Frayed
85
85
Detachment of Device or Device Component
81
81
Material Separation
75
75
Unable to Obtain Readings
70
70
Inadequacy of Device Shape and/or Size
69
69
Telemetry Discrepancy
62
62
Material Protrusion/Extrusion
59
59
Device Stops Intermittently
57
57
Power Problem
56
56
Degraded
54
54
Unintended Movement
53
53
Component Missing
52
52
Bent
44
44
Device Damaged by Another Device
44
44
Loss of Power
41
41
Mechanical Problem
39
39
Inadequate Instructions for Non-Healthcare Professional
38
38
Kinked
37
37
Vibration
36
36
Electro-Static Discharge
36
36
Noise, Audible
36
36
Failure to Disconnect
29
29
Failure to Fire
29
29
Operating System Becomes Nonfunctional
28
28
Computer Software Problem
27
27
Ambient Noise Problem
25
25
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Inadequate Pain Relief
42714
42714
No Known Impact Or Consequence To Patient
18947
18949
Pain
18291
18294
No Code Available
12284
12284
No Clinical Signs, Symptoms or Conditions
11318
11318
Therapeutic Effects, Unexpected
10574
10580
Discomfort
7018
7018
Unspecified Infection
5282
5284
No Consequences Or Impact To Patient
5080
5081
Undesired Nerve Stimulation
3548
3548
Therapeutic Response, Decreased
3427
3428
Electric Shock
3255
3255
Complaint, Ill-Defined
3139
3140
Burning Sensation
2681
2681
Insufficient Information
2323
2323
Post Operative Wound Infection
1906
1906
Implant Pain
1732
1732
Device Overstimulation of Tissue
1624
1624
Bacterial Infection
1457
1457
Failure of Implant
1453
1453
Ambulation Difficulties
1127
1127
Swelling
961
961
Wound Dehiscence
946
946
Numbness
929
929
No Information
924
924
Fall
922
922
Erosion
877
877
Fluid Discharge
875
875
Cerebrospinal Fluid Leakage
852
852
Hematoma
801
801
Headache
687
687
Impaired Healing
600
600
Scar Tissue
583
584
Fever
541
541
Weight Changes
536
536
Paralysis
522
522
Death
509
509
Burn(s)
467
467
Tingling
457
457
Erythema
437
437
Muscle Weakness
421
421
Muscle Spasm(s)
419
419
Sleep Dysfunction
418
418
Purulent Discharge
369
369
Staphylococcus Aureus
351
351
Seroma
342
342
Irritation
337
337
Hypersensitivity/Allergic reaction
314
314
Pocket Erosion
310
310
Nausea
294
294
Weakness
285
285
Device Embedded In Tissue or Plaque
279
279
Swelling/ Edema
278
278
Inflammation
271
271
Bruise/Contusion
247
247
Itching Sensation
201
201
Abdominal Pain
199
199
Skin Erosion
197
197
Abscess
191
191
Hemorrhage/Bleeding
184
184
Anxiety
173
173
Nerve Damage
169
169
Neurological Deficit/Dysfunction
163
163
Rash
162
162
Alteration In Body Temperature
161
161
Seizures
157
157
Malaise
157
157
Incontinence
154
154
Vomiting
153
153
Discharge
150
150
Cramp(s) /Muscle Spasm(s)
148
148
Stroke/CVA
146
146
Shaking/Tremors
144
144
Skin Inflammation/ Irritation
135
135
Neuropathy
129
129
Dyspnea
123
123
Headache, Lumbar Puncture
123
123
Cramp(s)
118
118
Cognitive Changes
118
118
Paresthesia
117
117
Distress
116
116
Dizziness
111
111
Muscular Rigidity
111
111
Neck Pain
109
109
Sepsis
107
107
Chest Pain
104
104
Foreign Body Reaction
92
92
Urinary Retention
84
85
High Blood Pressure/ Hypertension
81
81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
78
78
Injury
77
77
Edema
75
75
Twitching
72
72
Loss of consciousness
71
71
Spinal Cord Injury
71
71
Skin Irritation
69
69
Reaction
68
68
Cellulitis
68
68
Chills
67
67
Patient Problem/Medical Problem
67
67
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Neuromodulation Corporation
II
May-26-2020
2
Medtronic Neuromodulation
II
May-23-2022
3
Medtronic Neuromodulation
II
Nov-24-2021
4
Medtronic Neuromodulation
II
Jul-28-2021
5
Medtronic Neuromodulation
II
May-06-2021
6
Medtronic Neuromodulation
II
Jan-14-2021
7
Medtronic Neuromodulation
II
Jul-13-2018
8
St. Jude Medical, Inc.
II
Oct-17-2017
9
St. Jude Medical, Inc.
II
Jul-07-2017
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