| Device Type ID | 3846 |
| Device Name | Implanted Subcortical Electrical Stimulator (motor Disorders) |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Neurology Branch (NSDN) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | MRU |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3846 |
| Device | Implanted Subcortical Electrical Stimulator (motor Disorders) |
| Product Code | MRU |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 140 |
Device Operates Differently Than Expected | 136 |
High Impedance | 71 |
Failure To Deliver Energy | 66 |
Device Displays Incorrect Message | 60 |
Battery Problem | 43 |
Migration Or Expulsion Of Device | 40 |
Break | 38 |
Low Battery | 37 |
Charging Problem | 35 |
Premature Discharge Of Battery | 32 |
Communication Or Transmission Problem | 31 |
Inappropriate Shock | 27 |
Low Impedance | 26 |
Malposition Of Device | 23 |
Intermittent Continuity | 21 |
Delayed Charge Time | 19 |
Impedance Problem | 18 |
Electromagnetic Compatibility Problem | 18 |
Improper Or Incorrect Procedure Or Method | 11 |
Electromagnetic Interference | 11 |
Unintended Collision | 10 |
Overheating Of Device | 10 |
Therapy Delivered To Incorrect Body Area | 9 |
Failure To Interrogate | 7 |
Unstable | 6 |
Energy Output Problem | 6 |
Material Deformation | 6 |
Pocket Stimulation | 5 |
Unexpected Therapeutic Results | 5 |
Electro-Static Discharge | 4 |
Connection Problem | 4 |
Display Or Visual Feedback Problem | 4 |
No Device Output | 4 |
Insufficient Information | 3 |
Material Integrity Problem | 3 |
Difficult To Remove | 2 |
Bent | 2 |
Noise, Audible | 2 |
Device Or Device Fragments Location Unknown | 2 |
Positioning Problem | 2 |
Disconnection | 2 |
Difficult To Insert | 2 |
Unable To Obtain Readings | 2 |
Patient Device Interaction Problem | 2 |
Environmental Compatibility Problem | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Shelf Life Exceeded | 1 |
Energy Output To Patient Tissue Incorrect | 1 |
Material Twisted / Bent | 1 |
Loss Of Data | 1 |
Vibration | 1 |
Unauthorized Access To Computer System | 1 |
Device Difficult To Program Or Calibrate | 1 |
Shipping Damage Or Problem | 1 |
Use Of Device Problem | 1 |
Activation, Positioning Or Separation Problem | 1 |
| Total Device Problems | 1020 |