MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-09 for ESTEEM 7002 / 7502 907002-002/907502-002 manufactured by Envoy Medical Corporation.
[123109010]
Device evaluation summary: test results from device manufacturing and dhr were reviewed. All components in question passed all functional testing in production and passed quality inspections. No anomalies associated with sterilization of product. No device failures are alleged. Tissue breakdown occured.
Patient Sequence No: 1, Text Type: N, H10
[123109011]
Envoy medical corp. Hq (emc) was notified on (b)(4) 2018, via complaint report of a foreign body reaction, leading to device/lead extrusion, posterior to the incision. Non-infection skin breakdown. Patient/clinical history with emc: (b)(6) 2012 -- implant, (b)(6) 2012 - activation, (b)(6) 2012 -- fitting, (b)(6) 2017 -- battery change, (b)(6) 2017 -- post battery change programming, (b)(6) 2018 -- sp removal - sterile wound dehiscense; complaint (b)(4), mdr filed, 3004007782-2018-00006. (b)(6) 2018 -- transducer removal (both, sensor & driver) - sterile wound dehiscense; complaint (b)(4) , mdr 3004007782-2018-00012. Patient had a previous non-infection wound dehiscense (mdr 3004007782-2018-00006), at which point the sp was removed to allow for healing. Transducers remained implanted for potential future re-implant of new sp. Patient again started to experience non-infection wound breakdown/ dehiscense and the remaining components were explanted to promote healing. Patient received reconstruction with prosthesis from the malleus to the stapes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2018-00012 |
| MDR Report Key | 7947660 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-09 |
| Date of Report | 2018-10-09 |
| Date of Event | 2018-09-11 |
| Date Mfgr Received | 2018-09-11 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2018-10-09 |
| 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. MAKSIM TROFIMOVICH |
| Manufacturer Street | 4875 WHITE BEAR PARKWAY |
| Manufacturer City | WHITE BEAR LAKE MN 551108057 |
| Manufacturer Country | US |
| Manufacturer Postal | 551108057 |
| Manufacturer Phone | 6513618029 |
| Manufacturer G1 | ENVOY MEDICAL CORPORATION |
| Manufacturer Street | 4875 WHITE BEAR PARKWAY |
| Manufacturer City | WHITE BEAR LAKE MN 551108057 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 551108057 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESTEEM |
| Generic Name | ESTEEM II, PRODUCT CODE: OAF |
| Product Code | OAF |
| Date Received | 2018-10-09 |
| Returned To Mfg | 2018-09-17 |
| Model Number | 7002 / 7502 |
| Catalog Number | 907002-002/907502-002 |
| Lot Number | EMC4389/4393 |
| Device Expiration Date | 2013-08-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENVOY MEDICAL CORPORATION |
| Manufacturer Address | 4875 WHITE BEAR PARKWAY WHITE BEAR LAKE MN 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-09 |