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 2018-01-08 for ESTEEM 7504 907504-001 manufactured by Envoy Medical Corp..
[97495398]
Patient Sequence No: 1, Text Type: N, H10
[97495399]
Patient complained of intermittent functionality of device. (b)(6) 2012 - patient initially implanted in left ear. Already had device in right ear since (b)(6) 2012. (b)(6) 2012 - left ear device activated - complained of taste disturbance, but no complaint of intermittency. (b)(6) 2014 - fitting - complained about word recognition and background noise, but no record of intermittency issues. (b)(6) 2015 - fitting - complained of intermittency - some troubleshooting and investigation was made and it was determined that a revision surgery was necessary. (b)(6) 2015 - revision surgery - driver capacitance fluctuated between 420 and 4200 during manual manipulation of the lead indicating possible hardware issue with driver assembly. Sp and driver was replaced during revision surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2015-00019 |
| MDR Report Key | 7172761 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2018-01-08 |
| Date of Report | 2015-10-13 |
| Date of Event | 2015-09-18 |
| Date Mfgr Received | 2015-10-07 |
| Device Manufacturer Date | 2012-09-17 |
| 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 | 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 DRIVER |
| Product Code | OAF |
| Date Received | 2018-01-08 |
| Returned To Mfg | 2015-10-07 |
| Model Number | 7504 |
| Catalog Number | 907504-001 |
| Lot Number | 907504-003 |
| Device Expiration Date | 2014-09-01 |
| 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 | 2018-01-08 |