FDA Adverse Event
Malfunction
Summary report: N
ESTEEM
MDR report key: 3964405
·
Received June 19, 2014
Report
- Report Number
- 3004007782-2014-00013
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Date of Event
- May 19, 2014
- Report Date
- June 13, 2014
- Manufacturer
- ENVOY MEDICAL
- Product Code
- OAF
- PMA / PMN Number
- P090018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2012. PT WAS IMPLANTED (RIGHT EAR) BY DR. (B)(6). ON (B)(6) 2013 FITTING: "THERE WAS ALSO A PEAK IN THE FB TEST AT -45DB AT 1500HZ." ON (B)(6) 2014 FITTING: PROGRAMMING OUT OF FB NOT POSSIBLE. ON (B)(6) 2014 TRANSFER OF CARE: PATIENT HAS BEEN REFERRED TO (B)(6). RELEASE WAS RECEIVED AND MEDICAL RECORDS SENT TO (B)(6). ON (B)(6) 2014 ENVOY BECOMES AWARE THAT A REVISION SURGERY HAS BEEN SCHEDULED. ON (B)(6) 2014 REVISION SURGERY. ON (B)(6) 2014 ENVOY RECEIVES THE DEVICE AND BEGINS ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 359386 | ESTEEM | OAF | ENVOY MEDICAL | 2001 | EMC0004477 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Required Intervention |