Definition: Weight Reduction By Peripheral Neuromodulation.
| Device Type ID | 2233 |
| Device Name | Neuromodulator For Obesity |
| Physical State | Pulse Generator With Leads |
| Technical Method | Neural Modulation With Implantable Electrical Pulse Generators. |
| Target Area | Enteric Nervous System |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PIM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2233 |
| Device | Neuromodulator For Obesity |
| Product Code | PIM |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Displays Incorrect Message | 37 |
Device Inoperable | 35 |
Electrical /Electronic Property Problem | 16 |
Low Impedance | 14 |
High Impedance | 11 |
Adverse Event Without Identified Device Or Use Problem | 9 |
Therapeutic Or Diagnostic Output Failure | 8 |
Use Of Device Problem | 7 |
Impedance Problem | 6 |
Visual Prompts Will Not Clear | 5 |
Material Twisted / Bent | 4 |
Fracture | 3 |
Material Distortion | 3 |
Material Separation | 2 |
Migration Or Expulsion Of Device | 2 |
Device Operates Differently Than Expected | 2 |
Low Readings | 2 |
Failure To Charge | 2 |
Activation Problem | 1 |
Connection Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Misconnection | 1 |
Device Stops Intermittently | 1 |
Bent | 1 |
Material Deformation | 1 |
Failure To Conduct | 1 |
Disconnection | 1 |
Loose Or Intermittent Connection | 1 |
Electrical Overstress | 1 |
Battery Problem: Low Impedance | 1 |
| Total Device Problems | 180 |