MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-25 for ESTEEM 7504 907504-003 manufactured by Envoy Medical Corp..
[109515066]
Test results from device manufacturing and dhr were reviewed. Driver (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
[109515067]
Envoy medical was able to recognize poor device performance on (b)(6) 2018. Patient/clinical history with emc: (b)(6) 2017 -- initial implant; (b)(6) 2018 -- activation and remote support; (b)(6) 2018 -- remote support; (b)(6) 2018 -- clinical review (determination of poor device performance).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2018-00008 |
| MDR Report Key | 7546652 |
| Date Received | 2018-05-25 |
| Date of Report | 2018-05-25 |
| Date of Event | 2018-04-26 |
| Device Manufacturer Date | 2017-12-07 |
| Date Added to Maude | 2018-05-25 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ESTEEM |
| Generic Name | ESTEEM II DRIVER TRANSDUCER (7504) |
| Product Code | OAF |
| Date Received | 2018-05-25 |
| Model Number | 7504 |
| Catalog Number | 907504-003 |
| Lot Number | EMC0006171 |
| Device Expiration Date | 2019-12-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2018-05-25 |