MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-08 for ESTEEM 2001 902001-003 manufactured by Envoy Medical Corp..
[99538151]
Device passed all functional testing. No anomalies associated with sterilization of product.
Patient Sequence No: 1, Text Type: N, H10
[99538152]
System explant due to pain and discomfort around sound processor. Patient history: (b)(6) 2012 - patient initially implanted, (b)(6) 2012 - fitting / activation, (b)(6) 2012 - fitting, (b)(6) 2013 - fitting, (b)(6) 2014 - fitting / sound event, (b)(6) 2015 - fitting, (b)(6) 2016 - fitting, (b)(6) 2016 - revision to address feedback - see mdr 3004007782-2016-00003. Root cause of feedback could not be determined. However, fibrotic tissue was noted in the middle ear and removed. On (b)(6) 2016 - fitting, (b)(6) 2017 - fitting / patient complained of discomfort since revision surgery in (b)(6) 2016. Recommended that patient see implanting surgeon, but patient wanted to try and be seen by their own otologist. On (b)(6) 2018 - system explant. Surgeon noted an "infected pocket" with approximately "2 cc of pus". Surgeon noted that no obvious infection was present pre-operatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2018-00001 |
| MDR Report Key | 7253273 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-08 |
| Date of Report | 2018-02-08 |
| Date of Event | 2018-01-10 |
| Date Mfgr Received | 2018-01-16 |
| Device Manufacturer Date | 2016-04-21 |
| Date Added to Maude | 2018-02-08 |
| 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 |
| 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESTEEM |
| Generic Name | ESTEEM II SYSTEM |
| Product Code | OAF |
| Date Received | 2018-02-08 |
| Returned To Mfg | 2018-01-16 |
| Model Number | 2001 |
| Catalog Number | 902001-003 |
| Lot Number | EMC0005722 |
| Device Expiration Date | 2016-06-02 |
| 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 | 2018-02-08 |