FDA Adverse Event
Other
Summary report: N
ESTEEM SYSTEM
MDR report key: 2912884
·
Received December 3, 2012
Report
- Report Number
- 3004007782-2012-00018
- Event Type
- Other
- Date Received
- December 3, 2012
- Date of Event
- June 11, 2012
- Report Date
- November 30, 2012
- Manufacturer
- ENVOY MEDICAL
- Product Code
- OAF
- PMA / PMN Number
- P090018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FACIAL NERVE WEAKNESS A KNOWN COMPLICATION OF MATOIDECTOMY. ENVOY MEDICAL HAS CONFIRMED WITH IMPLANTING SURGEON THAT THE ISSUE HAD RESOLVED. DEVICE WAS EXPLANTED. PT WAS RECONSTRUCTED WITH AN ENVOYCEM BRIDGE. EXPLANTED WAS NOT A RESULT OF THE FACIAL NERVE WEAKNESS. EXPLANT WAS DUE TO AN ABUNDANCE OF ADHESION PRESENT IN THE MASTOID. NOTE: LATE FILING OF REPORT AS PER DISCUSSION WITH (B)(4) 2012.
Description of Event or Problem · 1
FACIAL NERVE WEAKNESS REPORTED AT ACTIVATION. INITIAL IMPLANT (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESTEEM SYSTEM | OAF | ENVOY MEDICAL | 2001 | EMC0004391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other |