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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)
2020
2021
2022
2023
2024
2025
8
13
3
9
13
4
MDR Year
MDR Reports
MDR Events
2020
2323
2323
2021
2304
2304
2022
1957
1957
2023
1825
1825
2024
2075
2075
2025
547
547
Device Problems
MDRs with this Device Problem
Events in those MDRs
Migration
3484
3484
Therapeutic or Diagnostic Output Failure
1764
1764
Adverse Event Without Identified Device or Use Problem
1633
1633
High impedance
1623
1623
Fracture
1201
1201
Insufficient Information
297
297
Material Fragmentation
279
279
Use of Device Problem
274
274
Battery Problem
229
229
Wireless Communication Problem
221
221
Impedance Problem
166
166
Inappropriate/Inadequate Shock/Stimulation
105
105
Patient-Device Incompatibility
82
82
Disconnection
78
78
Low impedance
73
73
Failure to Deliver Energy
65
65
No Apparent Adverse Event
53
53
Break
48
48
Improper or Incorrect Procedure or Method
32
32
Therapy Delivered to Incorrect Body Area
29
29
Separation Failure
26
26
Material Twisted/Bent
21
21
Premature Elective Replacement Indicator
18
18
Material Split, Cut or Torn
17
17
Migration or Expulsion of Device
16
16
Temperature Problem
15
15
Difficult to Remove
13
13
Pocket Stimulation
13
13
Mechanical Jam
12
12
Failure to Advance
12
12
Unexpected Shutdown
10
10
Difficult to Insert
9
9
Intermittent Energy Output
7
7
Incomplete or Inadequate Connection
4
4
Failure to Disconnect
3
3
Premature Discharge of Battery
3
3
Material Separation
3
3
Energy Output Problem
3
3
Material Protrusion/Extrusion
2
2
Device Damaged by Another Device
2
2
Naturally Worn
2
2
Positioning Problem
2
2
Entrapment of Device
2
2
Material Frayed
2
2
Device Handling Problem
1
1
Charging Problem
1
1
Product Quality Problem
1
1
Detachment of Device or Device Component
1
1
Device Contamination with Chemical or Other Material
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Inadequate Pain Relief
7887
7887
Failure of Implant
942
942
No Clinical Signs, Symptoms or Conditions
786
786
Implant Pain
579
579
No Consequences Or Impact To Patient
253
253
Undesired Nerve Stimulation
240
240
Post Operative Wound Infection
211
211
Pain
170
170
Cerebrospinal Fluid Leakage
153
153
Unspecified Infection
151
151
Insufficient Information
150
150
Foreign Body In Patient
146
146
Device Embedded In Tissue or Plaque
98
98
Wound Dehiscence
82
82
Discomfort
75
75
Headache
73
73
Erosion
66
66
No Known Impact Or Consequence To Patient
58
58
Numbness
51
51
Muscle Weakness
37
37
Fluid Discharge
35
35
Burning Sensation
29
29
Scar Tissue
28
28
Cramp(s) /Muscle Spasm(s)
23
23
Hematoma
22
22
Fever
18
18
Vomiting
16
16
Skin Erosion
16
16
Hypersensitivity/Allergic reaction
15
15
Bacterial Infection
14
14
Fall
13
13
Twiddlers Syndrome
12
12
Movement Disorder
12
12
Nausea
11
11
Swelling/ Edema
11
11
Headache, Lumbar Puncture
11
11
Seroma
10
10
Decreased Respiratory Rate
10
10
Cardiac Arrest
9
9
Device Overstimulation of Tissue
7
7
Purulent Discharge
7
7
No Information
7
7
Death
6
6
Skin Inflammation/ Irritation
6
6
Convulsion/Seizure
6
6
Twiddlers Syndrome
5
5
Sepsis
5
5
Respiratory Arrest
5
5
Swelling
5
5
Incontinence
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Medical
II
Jul-16-2024
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