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 2017-12-15 for ESTEEM 2001 902001-003 manufactured by Envoy Medical Corp..
[95053624]
This report was initially submitted to the https://esgtest. Fda. Gov/ environment on 04/04/2016 rather than the https://esg. Fda. Gov/ environment. Submissions to the https://esgtest. Fda. Gov/ environment were conducted in good faith that envoy medical was following all mdr submission requirements per the 21cfr803 regulation. The issue is under corrective action investigation and this submission is part of the containment activity for that issue.
Patient Sequence No: 1, Text Type: N, H10
[95053625]
Post-auricular skin breakdown. History: (b)(6) 2015 - initial implant, no related issues. (b)(6) 2015 - fitting, no mention of skin irritation or breakdown. (b)(6) 2016 - transmastoid revision to address post-auricular skin breakdown. Area was reconstructed by plastic surgeon by shifting skin and temporalis muscle. Model 2001 sound processor (sp) was replaced simply because it had been exposed. Device's performance has not been affected by the tissue breakdown and patient was noted as "extremely satisfied" by the surgeon, dr. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2016-00002 |
| MDR Report Key | 7123656 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2017-12-15 |
| Date of Report | 2016-04-04 |
| Date of Event | 2016-03-10 |
| Date Mfgr Received | 2016-04-01 |
| Device Manufacturer Date | 2014-10-08 |
| 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 | 5000 TOWNSHIP PARKWAY |
| Manufacturer City | ST. PAUL MN 55110 |
| Manufacturer Country | US |
| Manufacturer Postal | 55110 |
| Manufacturer Phone | 6513618057 |
| Single Use | 3 |
| Remedial Action | OT |
| 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 | 2016-04-01 |
| Model Number | 2001 |
| Catalog Number | 902001-003 |
| Lot Number | EMC0005566 |
| Device Expiration Date | 2015-10-08 |
| 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 | 5000 TOWNSHIP PARKWAY ST. PAUL 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-15 |