Definition: The Device Is Indicated For The Adjunctive Long-term Treatment Of Chronic Or Recurrent Depression For Patients 18 Years Of Age Or Older Who Are Experiencing A Major Depressive Episode And Have Not Had An Adequate Response To Four Or More Adequate Ant
| Device Type ID | 3847 |
| Device Name | Stimulator, Autonomic Nerve, Implanted (depression) |
| 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 | MUZ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3847 |
| Device | Stimulator, Autonomic Nerve, Implanted (depression) |
| Product Code | MUZ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 94 |
Fracture | 36 |
High Impedance | 21 |
Insufficient Information | 8 |
Corroded | 6 |
Unexpected Therapeutic Results | 3 |
Energy Output To Patient Tissue Incorrect | 3 |
Mechanical Problem | 3 |
Premature End-of-Life Indicator | 3 |
Computer Software Problem | 2 |
Bent | 2 |
Communication Or Transmission Problem | 2 |
Device Operates Differently Than Expected | 2 |
Low Impedance | 2 |
Battery Problem | 2 |
Appropriate Term/Code Not Available | 2 |
Failure To Charge | 1 |
Failure To Interrogate | 1 |
Device Contamination With Body Fluid | 1 |
Device Inoperable | 1 |
Programming Issue | 1 |
Cable | 1 |
Difficult To Insert | 1 |
Low Battery | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Output Problem | 1 |
Fluid Leak | 1 |
Detachment Of Device Component | 1 |
Therapy Delivered To Incorrect Body Area | 1 |
Generator | 1 |
Failure To Power Up | 1 |
Operating System Version Or Upgrade Problem | 1 |
| Total Device Problems | 207 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cyberonics, Inc | II | Jun-19-2018 |