FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM.
MDR report key: 3965156
·
Received July 29, 2014
Report
- Report Number
- 6000034-2014-01040
- Event Type
- Malfunction
- Date Received
- July 29, 2014
- Date of Event
- September 3, 2014
- Report Date
- December 5, 2014
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 890027
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED JANUARY 19TH, 2015.
Additional Manufacturer Narrative · 1
(B)(4): THE IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2014; DURING THE SAME SURGERY, THE PATIENT WAS RE IMPLANTED WITH A NEW DEVICE. THE DEVICE HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, SEPTEMBER 14, 2014.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT LOST CONNECTION WITH THE INTERNAL DEVICE AND THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 440959 | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM. | MCM | MCM | COCHLEAR LTD. | CI22M | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention |