FDA Adverse Event
Injury
Summary report: N
HIRES 90K IMPLANT
MDR report key: 3962534
·
Received July 14, 2014
Report
- Report Number
- 3006556115-2014-00337
- Event Type
- Injury
- Date Received
- July 14, 2014
- Date of Event
- June 20, 2014
- Report Date
- June 23, 2014
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE COMPANY WAS INFORMED THAT THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT WAS REPORTEDLY A NONUSER. THERE ARE NO PLANS FOR REIMPLANTATION. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION; ONCE MORE INFORMATION IS AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409715 | HIRES 90K IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | CL-1400-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Required Intervention |