MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-04-25 for ESTEEM 7504 907504-003 manufactured by Envoy Medical Corp..
[106578735]
Device passed all manufacturing acceptance testing and quality inspection.
Patient Sequence No: 1, Text Type: N, H10
[106578736]
(b)(6) 2018 - following the battery change surgery, it was determined that there was a problem with the esteem system and it was not functioning. (b)(6) 2018 - diagnostic testing was performed, but the cause of the issue could not be determined and a revision surgery was scheduled for the next day. (b)(6) 2018 - revision surgery found that the esteem driver was not functioning and it was replaced with successful results. Patient history: (b)(6) 2012 - patient was implanted with the esteem system. (b)(6) 2012 - activation; (b)(6) 2012 - fitting; (b)(6) 2013 - fitting; (b)(6) 2015 - fitting; (b)(6) 2018 - battery change surgery; (b)(6) 2018 - audio and esteem diagnostics; (b)(6) 2018 - transmastoid revision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2018-00003 |
| MDR Report Key | 7462382 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-04-25 |
| Date of Event | 2018-03-29 |
| Date Mfgr Received | 2018-03-29 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2018-04-25 |
| 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 DRIVER |
| Product Code | OAF |
| Date Received | 2018-04-25 |
| Returned To Mfg | 2018-04-04 |
| Model Number | 7504 |
| Catalog Number | 907504-003 |
| Lot Number | EMC0004801 |
| Device Expiration Date | 2014-07-01 |
| 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 | 2018-04-25 |