FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1954397
·
Received January 10, 2011
Report
- Report Number
- 6000034-2011-00014
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- December 23, 2010
- Report Date
- April 11, 2011
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6), 2010, DURING THE SAME SURGERY THE PATIENT WAS RE-IMPLANTED WITH ANOTHER DEVICE. THIS REPORT IS FILED (B)(6), 2011.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT ACHIEVED MINIMAL PROGRESS SINCE IMPLANTATION. REPROGRAMMING ATTEMPTS WERE MADE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED (DATE NOT REPORTED) AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A MASTOID SURGICAL PROCEDURE THAT THE BUR WAS DULL. IT WAS ALSO REPORTED THAT THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT ANOTHER BUR WAS READILY AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
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. | CI24RE (CA) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Required Intervention |