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..
[96638100]
Device passed all manufacturing acceptance testing and quality inspection.
Patient Sequence No: 1, Text Type: N, H10
[96638101]
Surgery to address retracted lead. On (b)(6) 2008 -original right ear implant by dr. (b)(6). On (b)(6) 2008-turn on. On (b)(6) 2008 -enhancement to reposition sensor. On (b)(6) 2008-turn on/ on (b)(6) 2008-activation. On (b)(6) 2008- 2 month follow up. On (b)(6) 2009- fitting. On (b)(6) 2009-unscheduled fitting. On (b)(6) 2010- enhancement, to recement the sensor after it was found touching the tm. On (b)(6) 2010- turn on. On (b)(6) 2010- fitting. On (b)(6) 2011- fitting. On (b)(6) 2011-sp removal for wound dehiscence healing. On (b)(6) 2011-new sp implanted; normal. On (b)(6) 2011- new sp implant, after finding inadequate lead insertion from (b)(6) implantation; normal the sp was tested and found to pass all requirements of the final mfg functional test. Additionally, investigation into bal seal springs indicated normal retention force.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2016-00011 |
| MDR Report Key | 7170142 |
| Report Source | STUDY |
| Date Received | 2018-01-05 |
| Date of Report | 2016-10-24 |
| Date of Event | 2011-12-16 |
| Date Mfgr Received | 2012-01-25 |
| 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 | RL |
| 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 | 2012-01-25 |
| Model Number | 2001 |
| Catalog Number | 902001-002 |
| Lot Number | EMC0004291 |
| Device Expiration Date | 2012-06-09 |
| 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 |