MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-22 for ESTEEM 2001 902001-003 manufactured by Envoy Medical Corp..
[108922086]
Test results from device manufacturing and dhr were reviewed. Sound processor (sn (b)(4)) passed all functional testing in production. No anomalies associated with sterilization of product. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[108922087]
Envoy medical was notified on (b)(6) 2018 of wound dehiscence. Wound/tissue breakdown around sound processor resulted in exposure of device. Patient/clinical history with emc: on (b)(6) 2012 - initial implant. On (b)(6) 2012 - activation date. On (b)(6) 2012 - fitting. On (b)(6) 2017- battery change. On (b)(6) 2017 - post battery change programming and remote support. On (b)(6) 2018 - wound dehiscence reported (this report).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2018-00006 |
| MDR Report Key | 7534269 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-22 |
| Date of Event | 2018-05-21 |
| Device Manufacturer Date | 2017-02-07 |
| Date Added to Maude | 2018-05-22 |
| 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 Phone | 6513618057 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESTEEM |
| Generic Name | ESTEEM II |
| Product Code | OAF |
| Date Received | 2018-05-22 |
| Model Number | 2001 |
| Catalog Number | 902001-003 |
| Lot Number | EMC0006034 |
| Device Expiration Date | 2018-02-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENVOY MEDICAL CORP. |
| Manufacturer Address | 4875 WHITE BEAR PARKWAY WHITE BEAR LAKE MN 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-22 |