FDA Adverse Event
Injury
Summary report: N
HIRES 90 K IMPLANT
MDR report key: 3150110
·
Received May 31, 2013
Report
- Report Number
- 3006556115-2013-00231
- Event Type
- Injury
- Date Received
- May 31, 2013
- Date of Event
- May 11, 2013
- Report Date
- May 10, 2013
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PATIENT'S ELECTRODE ARRAY WAS NOT IN THE PROPER PLACE. THE PATIENT'S DEVICE WAS EXPLANTED AND THE PATIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO. ONCE MORE INFO IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240394 | HIRES 90 K IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | CI-1400-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |