| Device Type ID | 2196 |
| Device Name | Intestinal Stimulator |
| 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 | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | LNQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2196 |
| Device | Intestinal Stimulator |
| Product Code | LNQ |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 377 |
Adverse Event Without Identified Device Or Use Problem | 264 |
Inappropriate Shock | 164 |
Migration Or Expulsion Of Device | 128 |
High Impedance | 94 |
Electromagnetic Compatibility Problem | 71 |
Break | 68 |
Low Battery | 66 |
Failure To Deliver Energy | 54 |
Insufficient Information | 52 |
Unintended Collision | 47 |
Premature Discharge Of Battery | 45 |
Unstable | 41 |
Battery Problem | 39 |
Impedance Problem | 37 |
Electromagnetic Interference | 32 |
Malposition Of Device | 25 |
Pocket Stimulation | 25 |
Energy Output Problem | 24 |
Intermittent Continuity | 22 |
Device Displays Incorrect Message | 19 |
Communication Or Transmission Problem | 19 |
Therapy Delivered To Incorrect Body Area | 18 |
Material Deformation | 18 |
Overheating Of Device | 17 |
Positioning Problem | 15 |
Failure To Interrogate | 15 |
Patient Device Interaction Problem | 14 |
Disconnection | 11 |
Entrapment Of Device | 11 |
Device Or Device Fragments Location Unknown | 11 |
Shipping Damage Or Problem | 11 |
Connection Problem | 7 |
Human-Device Interface Problem | 7 |
Device Contamination With Chemical Or Other Material | 7 |
Low Impedance | 6 |
Energy Output To Patient Tissue Incorrect | 5 |
Unexpected Therapeutic Results | 4 |
Vibration | 4 |
Noise, Audible | 4 |
Shelf Life Exceeded | 4 |
No Device Output | 3 |
Environmental Compatibility Problem | 3 |
Loss Of Data | 3 |
Degraded | 3 |
Appropriate Term/Code Not Available | 2 |
Electro-Static Discharge | 2 |
Difficult To Remove | 2 |
Ambient Noise Problem | 2 |
Grounding Malfunction | 1 |
Unable To Obtain Readings | 1 |
Computer Software Problem | 1 |
Display Or Visual Feedback Problem | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Peeled / Delaminated | 1 |
Bent | 1 |
Data Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Unauthorized Access To Computer System | 1 |
Device Difficult To Program Or Calibrate | 1 |
| Total Device Problems | 1933 |