| Device Type ID | 228 |
| Device Name | Stimulator, Hypoglossal Nerve, Implanted, Apnea |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MNQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 228 |
| Device | Stimulator, Hypoglossal Nerve, Implanted, Apnea |
| Product Code | MNQ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 36 |
Appropriate Term/Code Not Available | 10 |
Insufficient Information | 10 |
Electrical /Electronic Property Problem | 5 |
No Apparent Adverse Event | 4 |
Patient Device Interaction Problem | 4 |
Malposition Of Device | 3 |
Device Sensing Problem | 3 |
Migration | 3 |
Migration Or Expulsion Of Device | 3 |
Device Operational Issue | 2 |
Use Of Device Problem | 2 |
Impedance Problem | 2 |
Positioning Problem | 1 |
Missing Value Reason | 1 |
Failure To Shut Off | 1 |
Naturally Worn | 1 |
Positioning Failure | 1 |
Device Dislodged Or Dislocated | 1 |
Device Abrasion From Instrument Or Another Object | 1 |
Material Split, Cut Or Torn | 1 |
Device Operates Differently Than Expected | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 97 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Inspire Medical Systems Inc. | II | Sep-04-2018 |