FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3103007
·
Received May 9, 2013
Report
- Report Number
- 6000034-2013-00874
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- April 30, 2013
- Report Date
- June 27, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THIS DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED SEPTEMBER 26, 2013.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT REPORTED THAT THE RECHARGEABLE BATTERY OVERHEATED. THE DEVICE WAS REQUESTED TO BE REMOVED FROM SERVICE AND A REPLACEMENT BATTERY WAS SHIPPED TO THE PATIENT.THERE ARE NO ALLEGATIONS OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203220 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CP900 ACCESSORY | L000018721 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Required Intervention |