MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2018-01-05 for ESTEEM 2001 902001-002 manufactured by Envoy Medical Corp..
[96583311]
The issue is under corrective action investigation and this submission is part of the containment activity for that issue.
Patient Sequence No: 1, Text Type: N, H10
[96583312]
Wound dehiscence. (b)(6) 2008 - original right ear implant by dr. (b)(6). (b)(6) 2008 -turn on; (b)(6) 2008 - enhancement to reposition the sensor, tissue noted; (b)(6) 2008 -turn on; (b)(6) 2008 - activation; (b)(6) 2008 - 2 month followup; (b)(6) 2009 - fitting; (b)(6) 2009 - unscheduled fitting; (b)(6) 2010 -enhancement to repair cement/tm joint restriction; (b)(6) 2010 - turn on, infection noticed; (b)(6) 2010 - fitting; (b)(6) 2011 - fitting, fluid noted; exposed sp, sensor lead noted; still negative for bacteria in cultures. (b)(6) 2011 - revision to allow the area around the sp to heal; no signs of infection noted, but does note chronic dehiscence and multiple surgical interventions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2016-00010 |
| MDR Report Key | 7170029 |
| Report Source | STUDY |
| Date Received | 2018-01-05 |
| Date of Report | 2016-10-21 |
| Date of Event | 2011-09-21 |
| 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 | 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 | 2011-09-26 |
| Model Number | 2001 |
| Catalog Number | 902001-002 |
| Lot Number | EMC0003507 |
| Device Expiration Date | 2011-05-04 |
| 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 |