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..
[109634505]
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. Returned product was evaluated per appropriate procedure and was found to have unacceptable capacitance output.
Patient Sequence No: 1, Text Type: N, H10
[109634506]
During initial implant, envoy medical was able to recognize poor device (sn (b)(4) performance on (b)(6) 2018. Replacement device was implanted. Patient/clinical history with emc on (b)(6) 2018 initial implant. Poor driver performance recognized. Replacement device implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2018-00007 |
| MDR Report Key | 7546648 |
| Date Received | 2018-05-25 |
| Date of Report | 2018-05-25 |
| Date of Event | 2018-05-10 |
| Date Mfgr Received | 2018-05-11 |
| 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 |
| Returned To Mfg | 2018-05-17 |
| Model Number | 7504 |
| Catalog Number | 907504-003 |
| Lot Number | EMC0006171 |
| Device Expiration Date | 2019-12-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 |