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 902001-003 manufactured by Envoy Medical Corp..
[96586146]
Patient Sequence No: 1, Text Type: N, H10
[96586147]
Sp causing feedback. On (b)(6) 2012- left ear implant by (b)(6). On (b)(6) 2012 - activation; report attached; perpetual feedback noted on (b)(6) 2012- fitting, report attached, feedback noted. On (b)(6) 2012- transcanal revision, to remove scar tissue. On (b)(6) 2013- fitting, report attached, perpetual feedback noted. On (b)(6) 2013- transmastoid revison, due to feedback. Dr. (b)(6) noticed blood in sp header and lead ports. Saline injection of the sp showed that fluid came out the flat side of the header. Removing the leads and wiping off the leads, and re-inserting into the sp showed a reduction of the feedback. The sp was removed and replaced. On (b)(6) 2016 - commander dx before/after sp replacement confirms sp as source of feedback. Early incidence of feedback (immediately at activation (b)(6) 2012) makes abrasion unlikely. Inspection of returned device confirm damage to sp header, likely by surgical instrument or sutures during initial implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2016-00012 |
| MDR Report Key | 7170161 |
| Report Source | STUDY |
| Date Received | 2018-01-05 |
| Date of Report | 2016-10-24 |
| Date of Event | 2013-06-13 |
| Date Mfgr Received | 2013-06-17 |
| Device Manufacturer Date | 2012-04-19 |
| 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 | 2013-06-17 |
| Model Number | 2001 |
| Catalog Number | 902001-003 |
| Lot Number | EMC0004661 |
| Device Expiration Date | 2013-04-19 |
| 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 | 2018-01-05 |