FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2062711
·
Received April 19, 2011
Report
- Report Number
- 6000034-2011-00268
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- October 28, 2010
- Report Date
- March 28, 2012
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED (DATE UNKNOWN). IT IS UNKNOWN IF THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUEST BUT NOT YET RECEIVED AS OF THE DATE OF THIS REPORT. (B)(4).
Additional Manufacturer Narrative · 1
PER THE PATIENT'S SURGEON, THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE (B)(6) 2011. DEVICE NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED (B)(4) 2012.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. EXPLANT AND REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT (B)(6), 2011. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE; MCM | MCM | COCHLEAR LTD. | CI24R (ST) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Required Intervention |