MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-08 for ESTEEM 2001 902001-003 manufactured by Envoy Medical Corporation.
[139992637]
Patient is experiencing feedback that is consistent with electrical feedback, not mechanical feedback, after a battery change. An abnormal sensor dx result was documented, with feedback scan and max gain of 10/10 were all noted. The patient reported a low frequency feedback. Esteem diagnostics showed potential issue with the sensor (frequency measured at 250 hz and 500 hz were not the same as the stimulus). There was also a significantly abnormal feedback scan and max gain dropped from 30/30 to 10/10. The device is demonstrating feedback similarly to other confirmed cases of electrical feedback and there is no reason to believe that feed back is mechanical in nature. The device failed to accurately measure two of four frequencies of test tones. Based on available test and diagnostic data, the source of the feed back cannot be conclusively identified, however the data reasonably suggests that a reportable event has occurred, requiring revision. Patient has not yet been seen to evaluate the issue medically, however the available test data reasonably suggests that a revision will be required.
Patient Sequence No: 1, Text Type: N, H10
[139992638]
Envoy medical corp. (emc) was notified on (b)(6) 2019 a patient experiencing low frequency feed back after a battery change. Testing showed abnormal sensor diagnostics. Test results are consistent with electrical feedback, not mechanical feedback. Patient/clinical history with emc: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2019-00001 |
| MDR Report Key | 8404939 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-08 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-02-08 |
| Device Manufacturer Date | 2018-05-31 |
| Date Added to Maude | 2019-03-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MAKSIM TROFIMOVICH |
| Manufacturer Street | 4875 WHITE BEAR PARKWAY |
| Manufacturer City | WHITE BEAR LAKE MN 551108057 |
| Manufacturer Country | US |
| Manufacturer Postal | 551108057 |
| Manufacturer Phone | 6513618029 |
| Manufacturer G1 | ENVOY MEDICAL CORPORATION |
| Manufacturer Street | 4875 WHITE BEAR PARKWAY |
| Manufacturer City | WHITE BEAR LAKE MN 551108057 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 551108057 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESTEEM |
| Generic Name | ESTEEM II, PRODUCT CODE: OAF |
| Product Code | OAF |
| Date Received | 2019-03-08 |
| Model Number | 2001 |
| Catalog Number | 902001-003 |
| Lot Number | EMC0006290 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENVOY MEDICAL CORPORATION |
| Manufacturer Address | 4875 WHITE BEAR PARKWAY WHITE BEAR LAKE MN 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-08 |