MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2018-01-08 for ESTEEM 2001 902001-003 manufactured by Envoy Medical Corp..
[96671614]
Device met all manufacturing specifications. No nonconformances noted in manufacturing process. Device was manufactured on deviation d-0234, which allowed the use of epoxy after expiration date. The expiration date is set to ensure that the epoxy is fluid enough to be able to be applied during manufacturing processes. Expired epoxy was qualified under released qualification procedures to ensure that it met all requirements for useability and curability. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[96671615]
- patient reports exposed sound processor immediately posterior to the pinna. - surgeon evaluated the exposed processor and noted that the sp has shifted anteriorly, drifting from its initial spot in the sound processor well, and it pressing on the pinna. - surgeon does not see any signs of infection. History: on (b)(6) 2012 - initial implant, no related issues. On (b)(6) 2012 - fitting, no mention of skin irritation or breakdown. On (b)(6) 2012 - fitting, no mention of skin irritation or breakdown. On (b)(6) 2014 - fitting, no mention of skin irritation or breakdown. On (b)(6) 2014 - fitting, no mention of skin irritation or breakdown. On (b)(6) 2015 - battery check, no mention of skin irritation or breakdown. On (b)(6) 2015 - battery replacement surgery. On (b)(6) 2016 - envoy receives report of onset of dehiscence over sp. On (b)(6) 2016 - revision surgery to remove sp and allow healing. Surgeon plans to implant a replacement sp once healing has sufficiently progressed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2016-00016 |
| MDR Report Key | 7172340 |
| Report Source | STUDY |
| Date Received | 2018-01-08 |
| Date of Report | 2016-12-20 |
| Date of Event | 2016-11-28 |
| Date Mfgr Received | 2016-12-14 |
| Device Manufacturer Date | 2014-10-08 |
| 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 | 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 | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESTEEM |
| Generic Name | ESTEEM II SP |
| Product Code | OAF |
| Date Received | 2018-01-08 |
| Returned To Mfg | 2016-12-14 |
| Model Number | 2001 |
| Catalog Number | 902001-003 |
| Lot Number | EMC0005722 |
| Device Expiration Date | 2016-06-02 |
| 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 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-08 |