MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2018-01-17 for ESTEEM manufactured by Envoy Medical Corporation.
[97586476]
Patient Sequence No: 1, Text Type: N, H10
[97586477]
Taste disturbance reported after. On (b)(6) 2012 - initial implant. On (b)(6) 2012 - activation - patient reported taste disturbance at activation. This is common due to the severing of the chorda tympani during implant surgery. Patients are informed that this is a likely event. On (b)(6) 2012 - analysis - patient was experiencing some intermittency in device performance. System analysis was performed and confirmed that function is below expectations. Further analysis is needed. On (b)(6) 2012 - fitting - pe tube is placed in tm. Patient still experiencing intermittency and hearing some "rushing" sounds in implanted ear. No mention of taste disturbance. On (b)(6) 2012 - fitting - patient still experiencing intermittency. No mention of taste disturbances. On (b)(6) 2012 - revision - driver lead had failed. System was explanted and replaced. See mdr 3004007782-2013-00008 regarding this issue. On (b)(6) 2013 - fitting - patient experiencing taste disturbances more than 1 year post implant. However, patent had revision surgery on (b)(6) 2012 (2 months prior) and it is likely that the chorda tympani was disturbed during this procedure. On (b)(6) 2013 - fitting - patient has indicated that taste disturbance is subsiding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2013-00003 |
| MDR Report Key | 7201426 |
| Report Source | STUDY |
| Date Received | 2018-01-17 |
| Date of Report | 2013-01-03 |
| Date of Event | 2013-01-02 |
| Date Mfgr Received | 2013-01-03 |
| Date Added to Maude | 2018-01-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR TODD KOEPPEL |
| Manufacturer Street | 4875 WHITE BEAR PARKWAY |
| Manufacturer City | WHITE BEAR LAKE MN 55110 |
| Manufacturer Country | US |
| Manufacturer Postal | 55110 |
| Manufacturer G1 | ENVOY MEDICAL CORPORATION |
| Manufacturer Street | 4875 WHITE BEAR PARKWAY |
| Manufacturer City | WHITE BEAR LAKE MN 55110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55110 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESTEEM |
| Generic Name | ESTEEM II SYSTEM |
| Product Code | OAF |
| Date Received | 2018-01-17 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENVOY MEDICAL CORPORATION |
| Manufacturer Address | 4875 WHITE BEAR PARKWAY WHITE BEAR LAKE MN 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-17 |