FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 4180274
·
Received October 17, 2014
Report
- Report Number
- 6000034-2014-01459
- Event Type
- Malfunction
- Date Received
- October 17, 2014
- Date of Event
- September 25, 2014
- Report Date
- January 20, 2016
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED JANUARY 22, 2016.
Additional Manufacturer Narrative · 1
PER THE PATIENTS SURGEON, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED). IT IS UNKNOWN IF RE-IMPLANTATION IS PLANNED AS OF THE DATE OF THIS REPORT, DECEMBER 2ND, 2015.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT AND LOSS OF CONNECTION TO THE INTERNAL DEVICE FOLLOWING AN ACCIDENT RESULTING IN TRAUMA ON (B)(6) 2014 (SPECIFIC DETAILS NOT REPORTED). THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS. IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, (B)(6), 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 662450 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI24R (ST) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Required Intervention |