MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2018-01-09 for ESTEEM 2001 902001-003 manufactured by Envoy Medical Corp..
[96812106]
Submissions to the https://esgtest. Fda. Gov/ environment were conducted in good faith that envoy medical was following all mdr submission requirements per the 21cfr803 regulation. The issue is under corrective action investigation and this submission is part of the containment activity for that issue.
Patient Sequence No: 1, Text Type: N, H10
[96812107]
Post-auricular skin breakdown. At the time of the procedure, the patient's leads and header were visible. The likely reason for the issue was an anterior sp and the patient's use of eye glasses, resulting in excessive skin tension. Revision surgery was performed to repair wound. History: (b)(6) 2006 - initial implant; (b)(6) 2006 - follow up visit - no issues; (b)(6) 2009 - battery replacement - no issues; (b)(6) 2014 - battery replacement - no issues; (b)(6) 2014 - fitting - no indication of wound in reports, no issues; (b)(6) 2015 - revision surgery to repair wound. Sp was replaced at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2015-00018 |
| MDR Report Key | 7176880 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2018-01-09 |
| Date of Report | 2015-10-13 |
| Date of Event | 2015-09-25 |
| Date Mfgr Received | 2015-09-30 |
| Date Added to Maude | 2018-01-09 |
| 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 SP |
| Product Code | OAF |
| Date Received | 2018-01-09 |
| Returned To Mfg | 2015-09-30 |
| Model Number | 2001 |
| Catalog Number | 902001-003 |
| Lot Number | EMC0005337 |
| Device Expiration Date | 2014-08-23 |
| 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 MN 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-09 |