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 7002 907002-002 manufactured by Envoy Medical Corp..
[96636857]
Physician indicated to envoy that he had inadvertently damaged the sensor lead during the battery replacement surgery when he was attempting to dissect a portion of soft-tissue and inadvertently cut the lead as well.
Patient Sequence No: 1, Text Type: N, H10
[96636858]
Patient underwent a battery change procedure on (b)(6) 2016. Following the procedure, it was noted that the device did not provide any benefit. Patient reported brief, intermittent operation. Patient underwent a revision surgery on (b)(6) 2016 and it was determined that the esteem ii sensor lead was damaged. The sensor was replaced and benefit was restored to the patient. On (b)(6) 2012 - initial implant. On (b)(6) 2012 - activation. On (b)(6) 2016 - battery change. On (b)(6) 2016 - onset of intermittency symptoms. On (b)(6) 2016 - revision surgery, discovered damaged sensor lead, sensor was replaced and normal operation was restored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004007782-2016-00015 |
| MDR Report Key | 7171975 |
| Report Source | STUDY |
| Date Received | 2018-01-08 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-11-28 |
| 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 SENSOR |
| Product Code | OAF |
| Date Received | 2018-01-08 |
| Returned To Mfg | 2016-12-05 |
| Model Number | 7002 |
| Catalog Number | 907002-002 |
| Lot Number | EMC0004394 |
| Device Expiration Date | 2014-01-01 |
| 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 |