Definition: Stimulation Of The Dorsal Root Ganglion For The Treatment Of Chronic, Intractable Pain Of The Lower Limbs.
| Device Type ID | 3866 |
| Device Name | Dorsal Root Ganglion Stimulator For Pain Relief |
| Physical State | Main Components Include Implanted Leads, Implanted Neurostimulator, And External Programmers |
| Technical Method | Uses Electrical Stimulation To The Dorsal Root Ganglion To Relieve Chronic, Intractable Pain |
| Target Area | Dorsal Root Ganglion |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Psychiatry Branch (NSDP) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PMP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3866 |
| Device | Dorsal Root Ganglion Stimulator For Pain Relief |
| Product Code | PMP |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2686 |
High Impedance | 275 |
Fracture | 230 |
Impedance Problem | 165 |
Low Impedance | 47 |
Disconnection | 35 |
No Device Output | 27 |
Communication Or Transmission Problem | 19 |
Break | 14 |
Device Inoperable | 12 |
Device Damaged By Another Device | 10 |
Premature Elective Replacement Indicator | 9 |
Kinked | 9 |
Material Fragmentation | 6 |
Material Separation | 6 |
Difficult To Insert | 5 |
Improper Or Incorrect Procedure Or Method | 5 |
Difficult To Remove | 5 |
Application Program Freezes, Becomes Nonfunctional | 5 |
Material Split, Cut Or Torn | 5 |
Device Stops Intermittently | 4 |
Device Operates Differently Than Expected | 3 |
Material Twisted / Bent | 3 |
Device Dislodged Or Dislocated | 3 |
Device Displays Incorrect Message | 3 |
Premature End-of-Life Indicator | 3 |
Wireless Communication Problem | 3 |
Installation-Related Problem | 2 |
Material Protrusion / Extrusion | 2 |
Device Issue | 2 |
Detachment Of Device Or Device Component | 2 |
Unexpected Therapeutic Results | 2 |
Device Contamination With Body Fluid | 1 |
Sparking | 1 |
Material Frayed | 1 |
Screw | 1 |
Use Of Device Problem | 1 |
Cut In Material | 1 |
Device Damaged Prior To Use | 1 |
Low Battery | 1 |
Off-Label Use | 1 |
| Total Device Problems | 3616 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | St. Jude Medical, Inc. | II | Mar-23-2018 |