MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-22 for ESTEEM 2001 902001-003 manufactured by Envoy Medical Corp..
[108921817]
No device malfunction alleged. Device was explanted and wound repaired to promote healing. Infection was likely secondary to the wound dehiscence due to the surgeon's statement that the dehiscence was caused by skin breakdown and there were no sterility issues indicated by the dhr review and the culture showed no infection.
Patient Sequence No: 1, Text Type: N, H10
[108921818]
Sterile wound dehiscence history: (b)(6) 2012 - initial implant, no related issues. (b)(6) 2012 - activation. (b)(6) 2012 - fitting. (b)(6) 2013 - fitting. (b)(6) 2014 - fitting. (b)(6) 2017 - battery check. (b)(6) 2017 - normal battery change. (b)(6) 2018 - patient's spouse contacted envoy medical to notify us that the patient's incision has opened up. No infection present. (b)(6) 2018 - explant surgery to remove esteem system. A culture was taken to check for infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2018-00004 |
| MDR Report Key | 7534268 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-22 |
| Date of Event | 2018-04-16 |
| Date Added to Maude | 2018-05-22 |
| 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESTEEM |
| Generic Name | ESTEEM II SP |
| Product Code | OAF |
| Date Received | 2018-05-22 |
| Returned To Mfg | 2018-04-26 |
| Model Number | 2001 |
| Catalog Number | 902001-003 |
| Lot Number | EMC0006101 |
| Device Expiration Date | 2018-03-23 |
| 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 | 2018-05-22 |