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 |