MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2018-01-08 for ESTEEM 7502 907502-002 manufactured by Envoy Medical Corp..
[96625004]
Failure mode determined to be a design issue with leads manufactured by oscor. Issue was investigated under envoy medical capa (b)(4). Corrective action was to redesign the leads and manufacture in-house at envoy medical. Corrective action has proved effective.
Patient Sequence No: 1, Text Type: N, H10
[96625005]
On (b)(6) 2016 - patient complained that device was intermittent. Patient had undergone a battery replacement four days prior to onset of intermittency. On (b)(6) 2011 - initial implant. On (b)(6) 2012 - enhancement surgery. On (b)(6) 2016 - battery change. On (b)(6) 2016 - onset of intermittency symptoms. On "(b)(6) 2019" - fitting. X-ray of device indicates full lead insertion. On (b)(6) 2016 - case review. Revision surgery recommended to investigate. On (b)(6) 2016 - revision surgery. Damaged driver lead found. Driver was replaced to correct the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2016-00014 |
| MDR Report Key | 7171875 |
| Report Source | STUDY |
| Date Received | 2018-01-08 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-10-28 |
| Date Mfgr Received | 2016-12-05 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2018-01-08 |
| 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 | 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 | 2018-01-08 |
| Returned To Mfg | 2016-12-05 |
| Model Number | 7502 |
| Catalog Number | 907502-002 |
| Lot Number | EMC0004078 |
| Device Expiration Date | 2012-10-01 |
| 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 | 4875 WHITE BEAR PARKWAY WHITE BEAR LAKE MN 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-08 |