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TPLC
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Device
dorsal root ganglion stimulator for pain relief
Definition
Stimulation of the dorsal root ganglion for the treatment of chronic, intractable pain of the lower limbs.
Product Code
PMP
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
5
8
13
3
9
2
MDR Year
MDR Reports
MDR Events
2019
2548
2548
2020
2323
2323
2021
2304
2304
2022
1957
1957
2023
1826
1826
2024
367
367
Device Problems
MDRs with this Device Problem
Events in those MDRs
Migration
3112
3112
Adverse Event Without Identified Device or Use Problem
2596
2596
Therapeutic or Diagnostic Output Failure
1779
1779
High impedance
1570
1570
Fracture
1123
1123
Insufficient Information
285
285
Material Fragmentation
241
241
Wireless Communication Problem
210
210
Battery Problem
183
183
Use of Device Problem
179
179
Impedance Problem
178
178
Disconnection
119
119
Patient-Device Incompatibility
108
108
Inappropriate/Inadequate Shock/Stimulation
96
96
Low impedance
68
68
Failure to Deliver Energy
66
66
Premature Elective Replacement Indicator
54
54
Break
44
44
Migration or Expulsion of Device
34
34
No Apparent Adverse Event
34
34
Therapy Delivered to Incorrect Body Area
27
27
Improper or Incorrect Procedure or Method
25
25
No Device Output
23
23
Separation Failure
21
21
Material Twisted/Bent
20
20
Material Split, Cut or Torn
19
19
Unexpected Shutdown
14
14
Difficult to Remove
14
14
Mechanical Jam
12
12
Failure to Advance
11
11
Premature Discharge of Battery
9
9
Temperature Problem
9
9
Intermittent Energy Output
7
7
Application Program Freezes, Becomes Nonfunctional
7
7
Material Separation
7
7
Pocket Stimulation
7
7
Difficult to Insert
6
6
Device Damaged by Another Device
5
5
Material Frayed
4
4
Energy Output Problem
3
3
High Readings
3
3
Failure to Disconnect
3
3
Communication or Transmission Problem
3
3
Positioning Problem
3
3
Incomplete or Inadequate Connection
3
3
Appropriate Term/Code Not Available
2
2
Premature End-of-Life Indicator
2
2
Entrapment of Device
2
2
Corroded
1
1
Loose or Intermittent Connection
1
1
Output above Specifications
1
1
Defibrillation/Stimulation Problem
1
1
Loss of Data
1
1
Detachment of Device or Device Component
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Application Program Problem
1
1
Product Quality Problem
1
1
Device Handling Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Deformation Due to Compressive Stress
1
1
Charging Problem
1
1
Naturally Worn
1
1
Material Protrusion/Extrusion
1
1
Patient Device Interaction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Inadequate Pain Relief
8132
8132
No Clinical Signs, Symptoms or Conditions
597
597
No Consequences Or Impact To Patient
516
516
Implant Pain
409
409
Pain
289
289
Failure of Implant
285
285
Cerebrospinal Fluid Leakage
203
203
Undesired Nerve Stimulation
200
200
Post Operative Wound Infection
171
171
Unspecified Infection
157
157
Discomfort
154
154
Insufficient Information
115
115
No Known Impact Or Consequence To Patient
92
92
Wound Dehiscence
83
83
Headache
80
80
Fall
76
76
Numbness
67
67
Erosion
64
64
Foreign Body In Patient
56
56
Device Embedded In Tissue or Plaque
51
51
Muscle Weakness
42
42
Headache, Lumbar Puncture
40
40
Hematoma
37
37
Device Overstimulation of Tissue
32
32
Fever
24
24
Scar Tissue
23
23
Vomiting
22
22
Burning Sensation
21
21
Weakness
20
20
Fluid Discharge
20
20
Twiddlers Syndrome
16
16
Nausea
15
15
Bacterial Infection
15
15
Death
13
13
Cramp(s) /Muscle Spasm(s)
13
13
Hypersensitivity/Allergic reaction
12
12
Muscle Spasm(s)
11
11
Cramp(s)
10
10
Decreased Respiratory Rate
10
10
Skin Erosion
10
10
Seroma
10
10
Weight Changes
9
9
Purulent Discharge
9
9
Cardiac Arrest
8
8
Therapeutic Effects, Unexpected
8
8
Impaired Healing
8
8
Swelling
8
8
Movement Disorder
8
8
No Information
7
7
Dizziness
6
6
Convulsion/Seizure
6
6
Aspiration/Inhalation
5
5
Abdominal Pain
5
5
Seizures
5
5
Coma
5
5
Skin Inflammation/ Irritation
5
5
Swelling/ Edema
5
5
Dyspnea
5
5
Apnea
4
4
Paralysis
4
4
Ambulation Difficulties
4
4
Incontinence
4
4
Respiratory Distress
4
4
Twitching
4
4
Shock
4
4
Respiratory Arrest
4
4
Arrhythmia
4
4
Cyst(s)
3
3
Pulmonary Embolism
3
3
Reaction to Medicinal Component of Device
3
3
Pocket Erosion
3
3
Rash
3
3
Patient Problem/Medical Problem
3
3
Erectile Dysfunction
3
3
Edema
3
3
Hemorrhage/Bleeding
3
3
Low Oxygen Saturation
3
3
Neurological Deficit/Dysfunction
3
3
Respiratory Failure
2
2
Myocardial Infarction
2
2
Skin Irritation
2
2
Shock from Patient Lead(s)
2
2
Neck Pain
2
2
Erythema
2
2
Air Embolism
2
2
Balance Problems
2
2
Atrial Fibrillation
2
2
Blister
2
2
Paraplegia
2
2
Reaction
2
2
Sepsis
2
2
Shock, Traumatic
2
2
Vertigo
2
2
Spinal Cord Injury
2
2
Chills
2
2
Neck Stiffness
2
2
Twiddlers Syndrome
2
2
Embolism/Embolus
2
2
Stroke/CVA
2
2
Unspecified Tissue Injury
2
2
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