MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2018-01-05 for ESTEEM 2001 902001-002 manufactured by Envoy Medical Corp..
[96590795]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[96590796]
Explant due to infection around implant site shortly after revision surgery. On (b)(6) 2010 - original right ear implant by dr. (b)(6). On (b)(6) 2010- turn on, feedback noticed. Pt wants more gain. On (b)(6) 2010, fitting, feedback noted. On (b)(6) 2010, fitting, feedback noted. On (b)(6) 2011, trans-mastoid revision to receive more gain, reduce feedback. A lot of fibrotic tissue found. On (b)(6) 2011, turn on. A seroma/abcess is found over the sp implantation area. On (b)(6) 2011, fitting. Infection noted behind the ear over the incision area of the sp. Patient is on antibiotics and physician says there is no inner ear infection. On (b)(6) 2011, necrotic tissue around the incision sight was noted and the entire device was explanted (no formal report available). Just under 6 months after (b)(6) 2011 trans-mastoid revision; symptoms of infection just 2 months after revision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2016-00008 |
| MDR Report Key | 7169602 |
| Report Source | FOREIGN,STUDY |
| Date Received | 2018-01-05 |
| Date of Report | 2016-10-21 |
| Date of Event | 2011-09-07 |
| Date Mfgr Received | 2011-09-26 |
| Date Added to Maude | 2018-01-05 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2018-01-05 |
| Returned To Mfg | 2011-09-26 |
| Model Number | 2001 |
| Catalog Number | 902001-002 |
| Lot Number | EMC0003507 |
| Device Expiration Date | 2011-05-05 |
| 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 | 1. Required No Informationntervention | 2018-01-05 |