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 7002, 7502 907002-002, 907502-002 manufactured by Envoy Medical Corp..
[96587505]
This report was initially submitted to the (b)(4) on 10/21/2016 rather than the (b)(4). Issue was discovered during a remediation project in 2016.
Patient Sequence No: 1, Text Type: N, H10
[96587506]
Explant of transducers due to rejection of foreign body. On (b)(6) 2010 - initial implant (as), (b)(4); bl pta=50 db from activation, implant report attached. On (b)(6) 2010 - activation shows normal benefit, pta=32 db; notes include exposed lead, recent ab treatment, on (b)(6) 2010- incision repair procedure (report attached); patient noted to be smoker, on (b)(6) 2010 - fitting (attached) showns normal benefit pta=31db; recurrence of infection included in notes on (b)(6) 2010 - incision repair procedure (report attached); sp removed in attempt to resolve infection, on (b)(6) 2010 - re-implant sp after infection healed (report attached), on (b)(6) 2013 - rma form received noting transducers returned due to "post-operative rejection of foreign body. " (attached) (b)(6) 2016 - summary: given documented history of chronic infection and multiple attempts to resolve surgically, this is most likely a full system explant due to infection. When audiometric data was collected, all indications suggest normal device function.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2016-00009 |
| MDR Report Key | 7169918 |
| Report Source | FOREIGN,STUDY |
| Date Received | 2018-01-05 |
| Date of Report | 2016-10-21 |
| Date of Event | 2013-10-22 |
| Date Mfgr Received | 2014-09-17 |
| 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 | 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 | 2018-01-05 |
| Returned To Mfg | 2014-09-17 |
| Model Number | 7002, 7502 |
| Catalog Number | 907002-002, 907502-002 |
| Lot Number | EMC0002905, EMC0002906 |
| Device Expiration Date | 2011-01-01 |
| 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 |