FDA Adverse Event
Malfunction
Summary report: N
HIRES 90K ADVANTAGE IMPLANT
MDR report key: 3905738
·
Received May 28, 2014
Report
- Report Number
- 3006556115-2014-00260
- Event Type
- Malfunction
- Date Received
- May 28, 2014
- Date of Event
- April 8, 2014
- Report Date
- May 7, 2014
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PATIENT DEVICE WAS REPORTEDLY EXPLANTED DUE TO A SUSPECTED DEVICE FAILURE. THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. ADVANCED BIONICS IS CURRENTLY IN THE PROCESS OF GATHERING ADDITIONAL INFO. WHEN ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 315067 | HIRES 90K ADVANTAGE IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | CI-1500-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |