MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2017-12-15 for ESTEEM 2001 902001-003 manufactured by Envoy Medical Corp..
[95052051]
Patient Sequence No: 1, Text Type: N, H10
[95052052]
Sterile wound dehiscence. Wound dehiscence was surgically repaired on (b)(6) 2016. Sound processor, model 902001, serial number (b)(4), was replaced after becoming exposed due to a dehiscence of the incision. A new sound processor, sn (b)(4), was implanted during the repair surgery. Patient had undergone a battery change procedure on (b)(6) 2016, and the incision from that procedure did not heal properly. Patient history: (b)(6) 2008 - initial implant, (b)(6) 2008 - device turned on, (b)(6) 2008 - activation, (b)(6) 2008 - unscheduled fitting, (b)(6) 2008 - 2-month followup, (b)(6) 2008 - unscheduled fitting, (b)(6) 2008 - unscheduled fitting, (b)(6) 2008 - 4-month followup, (b)(6) 2008 - unscheduled fitting, (b)(6) 2009 - 10-month followup, (b)(6) 2012 - battery change, (b)(6) 2016 - battery change, (b)(6) 2016 - wound dehiscence repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2016-00006 |
| MDR Report Key | 7123650 |
| Report Source | STUDY |
| Date Received | 2017-12-15 |
| Date of Report | 2016-07-07 |
| Date of Event | 2016-06-07 |
| Date Mfgr Received | 2016-06-13 |
| Device Manufacturer Date | 2016-06-13 |
| Date Added to Maude | 2017-12-15 |
| 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 | 2017-12-15 |
| Returned To Mfg | 2016-06-13 |
| Model Number | 2001 |
| Catalog Number | 902001-003 |
| Lot Number | EMC0005871 |
| Device Expiration Date | 2017-02-19 |
| 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 | 2017-12-15 |