MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2017-12-15 for ESTEEM 7502 907502-002 manufactured by Envoy Medical Corp.
[95733775]
This report was initially submitted to the (b)(4) on (b)(4) 2016 rather than the (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[95733776]
Patient reported in (b)(6) 2015 that the implant's performance was intermittent (the patient had not been seen since 2012). On (b)(6) 2015 envoygram and sensor diagnostic tests were not performed, however the feedback test was within range and max gain was 40/40. Device was reprogrammed and appeared to be doing well until (b)(6) 2015 when the patient reported the device suddenly stopped working. On (b)(6) 2016 testing indicated esteem driver performance is not satisfactory.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2016-00001 |
| MDR Report Key | 7122201 |
| Report Source | STUDY |
| Date Received | 2017-12-15 |
| Date of Report | 2016-04-13 |
| Date of Event | 2016-03-18 |
| Date Mfgr Received | 2016-03-28 |
| Device Manufacturer Date | 2012-02-28 |
| Date Added to Maude | 2017-12-15 |
| 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 | 5000 TOWNSHIP PARKWAY |
| Manufacturer City | ST. PAUL 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 | 2017-12-15 |
| Returned To Mfg | 2016-03-28 |
| Model Number | 7502 |
| Catalog Number | 907502-002 |
| Lot Number | EMC0004442 |
| Device Expiration Date | 2014-01-01 |
| 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 | 5000 TOWNSHIP PARKWAY ST. PAUL 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-15 |