MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-07-12 for ESTEEM 2001 902001-002 manufactured by Envoy Medical Corp..
[114043317]
Device evaluation summary: test results from device manufacturing and dhr were reviewed. Esteem ii sp (sn# (b)(4)) passed all functional testing in production. No anomalies associated with sterilization of product. Root cause findings indicate that there may have been insufficient adhesion of the dip coat to the header, resulting in fluid ingress/feedback. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[114043318]
Envoy medical was able to record physical evidence of header adhesive damage on (b)(6) 2018, via revision procedure. Patient/clinical history with emc: (b)(6) 2012 -- initial implant; (b)(6) 2012 -- fitting; (b)(6) 2012-- fitting; (b)(6) 2012-- analysis; (b)(6) 2012-- fitting; (b)(6) 2012 -- analysis; (b)(6) 2013-- fitting; (b)(6) 2013 -- fitting; (b)(6) 2014 -- fitting; (b)(6) 2014 -- fitting; (b)(6) 2014 -- sound event; (b)(6) 2016 -- fitting; (b)(6) 2017 -- fitting and remote support note; (b)(6) 2018 -- clinical analysis/case review regarding reported feedback. (b)(6) 2018 -- annual fitting/evaluation (b)(6) 2018 -- revision (in relation to (b)(4)) - sp replaced. (b)(6) 2018 -- product received at emc for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2018-00009 |
| MDR Report Key | 7682911 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-07-12 |
| Date of Report | 2018-07-12 |
| Date of Event | 2018-06-26 |
| Date Mfgr Received | 2018-07-02 |
| Device Manufacturer Date | 2011-11-16 |
| Date Added to Maude | 2018-07-12 |
| 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 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESTEEM |
| Generic Name | ESTEEM II SOUND PROCESSOR (MODEL 2001) |
| Product Code | OAF |
| Date Received | 2018-07-12 |
| Returned To Mfg | 2018-07-02 |
| Model Number | 2001 |
| Catalog Number | 902001-002 |
| Lot Number | EMC0004477 |
| 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 | 2018-07-12 |