FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3150654
·
Received June 6, 2013
Report
- Report Number
- 6000034-2013-01031
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Report Date
- September 16, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED ON SEPTEMBER 26, 2013.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT'S RECHARGEABLE BATTERY WOULD REPORTEDLY REMAIN HOT AFTER IT WAS CHARGED. THERE ARE NO REPORTS OF INJURY ASSOCIATED WITH THIS ISSUE. IT HAS BEEN REQUESTED THAT THE PRODUCT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250640 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CP800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |