MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-01-16 for ESTEEM 2001 902001-002 manufactured by Envoy Medical.
[97955914]
Device evaluation summary: test results from device manufacturing were reviewed. Sound processor (sn (b)(4)) passed all functional testing in production. A dhr review revealed that the device met all specifications and there were no manufacturing issues. The sound processor (sn (b)(4)) was evaluated upon receipt at envoy medical. A visual inspection revealed no device abnormalities except for some surface scuffing. The battery's voltage was tested and confirmed to be depleted. The battery was confirmed to be depleted at the time of explant. Root cause findings indicate that patient was programmed in settings that result in frequent or perpetual feedback without patient able to hear it (profound high frequency hearing loss). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[97955915]
Envoy medical was notified of a sound processor replacement due to battery depletion. This particular sound processor was implanted for 2. 3 years, which is less than the expected worst case battery life for normal operation of 2. 8 years. Clinical history: (b)(6) 2012 - original implant surgery. 03/31/2012 - revision to replace a damaged driver (reference (b)(4) & mdr: 3004007782-2012-00001), sp(b)(4) is implanted. (b)(6) 2012 - fitting. (b)(6) 2012 - fitting. (b)(6) 2012 - fitting. (b)(6) 2014 - envoy becomes aware patient will need a battery change. (sp had been implanted 2. 3 years < 2. 8 years expected worst case battery life for normal operation). (b)(6) 2014 - review of case indicates pt has severe high frequency hearing loss, the device may potentially have been in feedback above pt's ability to hear, the most likely cause of early battery depletion and a known issue. Additionally, patient wore a hearing aid in implanted ear which is not recommended as it exacerbates battery depletion. (b)(6) 2014 - sp is replaced in a surgery. During surgery, the new sp is programmed identically to the previously implanted sp and immediately goes into feedback, giving strong evidence indicating the returned sp had been in a continuous feedback state not detected by the patient due to his hearing loss profile.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2014-00016 |
| MDR Report Key | 7197853 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-01-16 |
| Date of Report | 2014-08-08 |
| Date of Event | 2014-07-10 |
| Date Mfgr Received | 2012-08-23 |
| Date Added to Maude | 2018-01-16 |
| 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 | 6513618000 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESTEEM |
| Generic Name | ESTEEM II SOUND PROCESSOR |
| Product Code | OAF |
| Date Received | 2018-01-16 |
| Returned To Mfg | 2014-07-13 |
| Model Number | 2001 |
| Catalog Number | 902001-002 |
| Lot Number | EMC0004438 |
| Device Expiration Date | 2012-11-16 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENVOY MEDICAL |
| Manufacturer Address | 4875 WHITE BEAR PARKWAY WHITE BEAR LAKE MN 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-16 |