FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 716736
·
Received May 19, 2006
Report
- Report Number
- 6000034-2006-00171
- Event Type
- Injury
- Date Received
- May 19, 2006
- Date of Event
- April 14, 2006
- Report Date
- May 10, 2006
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PER THE SURGEON'S REPORT, NO NRT RESPONSES COULD BE MEASURED DURING SURGERY. POST-OPERATIVELY, THE PT COULD NOT HEAR, BUT DEVICE TELEMETRY TESTS APPEARED NORMAL. THE SURGEON IMPLANTED A NDW DEVICE ON THE CONTRALATERAL SIDE 06. HE TRIED TO REMOVE THE FIRST DEVICE'S ELECTRODE ARRAY, BUT COULD NOT DUE TO COCHLEAR FIBROSIS AND DAMAGE TO THE ELECTRODE. HE EXPLANTED AND RETURNED THE RECEIVER/STIMULATOR COMPONENT FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | COCHLEAR LTD. | CI24R(ST) | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention |