MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2018-01-09 for ESTEEM 2001 902001-002 manufactured by Envoy Medical Corp..
[96856345]
This report was initially submitted to the (b)(4) environment on 09/15/2015 rather than the (b)(4) environment.
Patient Sequence No: 1, Text Type: N, H10
[96856346]
Pt was implanted with the esteem system (b)(6) 2012. Patient was activated on (b)(6) 2012 with satisfactory results. Patient had fitting on (b)(6) 2012 with satisfactory results. Patient had fitting on (b)(6) 2012 to reduce gain with satisfactory results. Patient had fitting on (b)(6) 2013 due to ear popping and other sounds with satisfactory results. Patient had fitting on (b)(6) 2014 due to feedback issues. Limited adjustments were made to reduce feedback patient had fitting on (b)(6) 2014 due to feedback issues and ear popping. Adjustment options were again limited due to feedback. Me issues and allergies believed to be cause of popping. Patient contacted envoy medical on (b)(6) 2015 to complain of ongoing feedback issues. On (b)(6) 2015 the esteem ii sp was explanted and replaced with another device with successful results. Sp was received by envoy on (b)(6) 2015. No pt injury other than revision surgery resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2015-00017 |
| MDR Report Key | 7177209 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2018-01-09 |
| Date of Report | 2015-09-14 |
| Date of Event | 2015-08-14 |
| Date Mfgr Received | 2015-08-18 |
| Device Manufacturer Date | 2011-11-16 |
| Date Added to Maude | 2018-01-09 |
| 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 | 5000 TOWNSHIP PARKWAY |
| Manufacturer City | ST. PAUL 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 |
| Product Code | OAF |
| Date Received | 2018-01-09 |
| Returned To Mfg | 2015-08-18 |
| Model Number | 2001 |
| Catalog Number | 902001-002 |
| Lot Number | EMC0004566 |
| Device Expiration Date | 2012-11-16 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENVOY MEDICAL CORP. |
| Manufacturer Address | 5000 TOWNSHIP PARKWAY ST. PAUL MN 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-09 |