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 902001-002 manufactured by Envoy Medical Corp..
[95813324]
Patient Sequence No: 1, Text Type: N, H10
[95813325]
Feedback and limited benefit with esteem ii. Patient reported a sudden onset of a loud noise (feedback) on (b)(6) 2016. A clinical visit was conducted on (b)(6) 2016 and the issue was confirmed. The device was turned off at that time while a plan was established to determine the cause. Testing data from esteem commander suggests a possible damaged sp header and middle-ear tissue growth. Exploratory surgery was scheduled and conducted to address both.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2016-00003 |
| MDR Report Key | 7123192 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-12-15 |
| Date of Report | 2016-05-31 |
| Date of Event | 2016-05-11 |
| Date Mfgr Received | 2016-05-16 |
| Device Manufacturer Date | 2011-11-16 |
| 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 LAKE MN 55110 |
| Manufacturer Country | US |
| Manufacturer Postal | 55110 |
| Manufacturer Phone | 6513618057 |
| Manufacturer G1 | ENVOY MEDICAL CORP. |
| Manufacturer Street | 4875 WHITE BEAR PARKWAY |
| Manufacturer City | WHITE BEAR LAKE MN 55110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55110 |
| 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 | 2016-05-16 |
| Model Number | 2001 |
| Catalog Number | 902001-002 |
| Lot Number | EMC0004438 |
| Device Expiration Date | 2012-11-16 |
| 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 |