MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-12-15 for ESTEEM 2001 902001-003 manufactured by Envoy Medical Corp.
[95811873]
Patient Sequence No: 1, Text Type: N, H10
[95811874]
Patient reported sudden loss in volume and feedback limitations initially around (b)(6) 2014. Nonsurgical approaches were attempted, but were unsuccessful. It appears that the patient had not been seen since 2014. A case review done in 2014 showed a decrease in max gain and an abnormal feedback test. Patient did well in 2012 and 2013, but a significant change in performance was noted in 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2016-00004 |
| MDR Report Key | 7123202 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-12-15 |
| Date of Report | 2016-06-09 |
| Date of Event | 2016-05-26 |
| Date Mfgr Received | 2016-05-26 |
| Device Manufacturer Date | 2012-04-19 |
| Date Added to Maude | 2017-12-15 |
| 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 TOWNSHIP 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 | 2017-12-15 |
| Returned To Mfg | 2016-05-27 |
| Model Number | 2001 |
| Catalog Number | 902001-003 |
| Lot Number | EMC0004661 |
| Device Expiration Date | 2013-04-19 |
| 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 | 2017-12-15 |