| Device Type ID | 3830 |
| Device Name | Stimulator, Spinal-cord, Totally Implanted For Pain Relief |
| 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 | LGW |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3830 |
| Device | Stimulator, Spinal-cord, Totally Implanted For Pain Relief |
| Product Code | LGW |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 17439 |
Device Operates Differently Than Expected | 9694 |
Charging Problem | 9492 |
Failure To Deliver Energy | 5477 |
Battery Problem | 5105 |
Communication Or Transmission Problem | 4825 |
High Impedance | 4777 |
Migration Or Expulsion Of Device | 4226 |
Device Displays Incorrect Message | 3650 |
Use Of Device Problem | 2497 |
Unintended Collision | 2496 |
Failure To Interrogate | 2348 |
Inappropriate Shock | 2342 |
Premature Elective Replacement Indicator | 2250 |
Low Battery | 2223 |
Improper Or Incorrect Procedure Or Method | 2018 |
Insufficient Information | 1934 |
Intermittent Continuity | 1579 |
Therapy Delivered To Incorrect Body Area | 1531 |
Device Inoperable | 1516 |
No Device Output | 1488 |
Delayed Charge Time | 1486 |
Malposition Of Device | 1477 |
Break | 1344 |
Overheating Of Device | 1171 |
Energy Output Problem | 1125 |
Connection Problem | 1057 |
No Apparent Adverse Event | 1023 |
Failure To Charge | 932 |
Electromagnetic Compatibility Problem | 905 |
Unexpected Therapeutic Results | 864 |
Impedance Problem | 844 |
Fracture | 807 |
Material Integrity Problem | 801 |
Unstable | 769 |
Positioning Problem | 725 |
Electromagnetic Interference | 586 |
Patient Device Interaction Problem | 511 |
Premature Discharge Of Battery | 465 |
Low Impedance | 459 |
Migration | 448 |
Energy Output To Patient Tissue Incorrect | 404 |
Application Program Freezes, Becomes Nonfunctional | 345 |
Display Or Visual Feedback Problem | 338 |
Device Or Device Fragments Location Unknown | 333 |
Disconnection | 273 |
Improper Device Output | 229 |
Pocket Stimulation | 226 |
Therapeutic Or Diagnostic Output Failure | 204 |
Kinked | 179 |
Telemetry Discrepancy | 169 |
Material Deformation | 156 |
Bent | 155 |
Device Difficult To Program Or Calibrate | 147 |
Failure To Power Up | 137 |
Loss Of Data | 129 |
Shipping Damage Or Problem | 102 |
Difficult To Remove | 101 |
Data Problem | 98 |
Device Dislodged Or Dislocated | 94 |
Environmental Compatibility Problem | 90 |
Premature End-of-Life Indicator | 89 |
Temperature Problem | 89 |
Difficult To Insert | 86 |
Human-Device Interface Problem | 86 |
Unable To Obtain Readings | 85 |
Device Contamination With Chemical Or Other Material | 85 |
Wireless Communication Problem | 84 |
Defective Device | 83 |
Inadequacy Of Device Shape And/or Size | 73 |
Inadequate Instructions For Non-Healthcare Professional | 65 |
Material Frayed | 65 |
Material Separation | 61 |
Device Stops Intermittently | 57 |
Component Missing | 53 |
Detachment Of Device Or Device Component | 52 |
Unintended Movement | 37 |
Appropriate Term/Code Not Available | 35 |
Electro-Static Discharge | 35 |
Material Protrusion / Extrusion | 32 |
Vibration | 31 |
Failure To Fire | 27 |
Noise, Audible | 26 |
Device Issue | 25 |
Degraded | 25 |
Power Problem | 23 |
Ambient Noise Problem | 23 |
Material Split, Cut Or Torn | 22 |
Shelf Life Exceeded | 21 |
Labelling, Instructions For Use Or Training Problem | 20 |
Failure To Align | 20 |
Unexpected Shutdown | 18 |
Cut In Material | 16 |
Operating System Becomes Nonfunctional | 15 |
Intermittent Energy Output | 14 |
Electrical Shorting | 13 |
Thermal Decomposition Of Device | 12 |
Device Expiration Issue | 11 |
Difficult To Position | 11 |
Material Fragmentation | 11 |
| Total Device Problems | 112251 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Neuromodulation | II | Jul-13-2018 |
| 2 | Medtronic Neuromodulation | II | Jun-07-2016 |
| 3 | Medtronic Neuromodulation | II | Feb-23-2016 |
| 4 | Medtronic Neuromodulation | II | Jun-26-2015 |
| 5 | Medtronic Neuromodulation | II | Apr-29-2014 |
| 6 | Nuvectra | II | Dec-17-2016 |
| 7 | Nuvectra | II | May-03-2016 |
| 8 | QiG Group LLC | II | Mar-18-2016 |
| 9 | St. Jude Medical, Inc. | II | Oct-17-2017 |
| 10 | St. Jude Medical, Inc. | II | Jul-07-2017 |