FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
MDR report key: 4232661
·
Received November 6, 2014
Report
- Report Number
- 6000034-2014-01576
- Event Type
- Injury
- Date Received
- November 6, 2014
- Date of Event
- October 6, 2014
- Report Date
- October 24, 2014
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE IS CURRENTLY UNAVAILABLE.
Additional Manufacturer Narrative · 1
THIS RECORD IS A DUPLICATE MDR OF MFR 6000034-2014-01625. ALL FUTURE INFORMATION WILL FILED UNDER MFR# 6000034-2014-01625.THIS REPORT IS FILED MARCH 26TH, 2015.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED STATIC AND POOR PERFORMANCE WITH DEVICE USE. SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2014; DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, NOVEMBER 6, 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712567 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. | MCM | MCM | COCHLEAR LTD. | CI422 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |