MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2018-01-08 for ESTEEM 2001 902001-002 manufactured by Envoy Medical Corp..
[96623067]
Device passed all manufacturing acceptance testing and quality inspection capa (b)(4) initiated to investigate and correct connector alignment issue.
Patient Sequence No: 1, Text Type: N, H10
[96623068]
On (b)(6) 2016 - patient had routine independent battery replacement surgery. Following the surgery, patient indicated that they were not able to hear out of the ear that had just been implanted. On (b)(6) 2016 - patient had revision surgery to determine cause of device not working. It was found that the driver lead was not fully inserted into the sp. Dr. Indicated that he had difficulty inserting the driver lead into the sp during the (b)(6) 2016 replacement surgery. The sp was replaced and the issue was resolved for the patient. Patient hearing and system functionality was fully restored with the revision surgery on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2016-00013 |
| MDR Report Key | 7171826 |
| Report Source | STUDY |
| Date Received | 2018-01-08 |
| Date of Report | 2016-11-04 |
| Date of Event | 2016-10-06 |
| Date Mfgr Received | 2016-10-17 |
| Date Added to Maude | 2018-01-08 |
| 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 | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESTEEM |
| Generic Name | ESTEEM II SP |
| Product Code | OAF |
| Date Received | 2018-01-08 |
| Returned To Mfg | 2016-10-17 |
| Model Number | 2001 |
| Catalog Number | 902001-002 |
| Lot Number | EMC0005893 |
| Device Expiration Date | 2017-03-28 |
| 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 | 1. Required No Informationntervention | 2018-01-08 |