FDA Adverse Event
Injury
Summary report: N
HIRES 90K IMPLANT
MDR report key: 3150148
·
Received May 30, 2013
Report
- Report Number
- 3006556115-2013-00224
- Event Type
- Injury
- Date Received
- May 30, 2013
- Date of Event
- May 28, 2013
- Report Date
- May 9, 2013
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REVEALED THAT THE PATIENT'S ELECTRODE ARRAY HAD BEEN POSITIONED INCORRECTLY DURING THE INITIAL IMPLANTATION. THE PATIENT UNDERWENT SURGERY TO REINSERT THE ELECTRODE ARRAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238256 | HIRES 90K IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | CI-1400-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention |