FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
MDR report key: 3971111
·
Received July 31, 2014
Report
- Report Number
- 6000034-2014-01153
- Event Type
- Injury
- Date Received
- July 31, 2014
- Date of Event
- June 30, 2014
- Report Date
- September 18, 2014
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2014, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME PROCEDURE. THIS REPORT IS FILED MARCH 20TH, 2015.
Additional Manufacturer Narrative · 1
(B)(4). THE IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT LOST CONNECTION TO THE INTERNAL DEVICE (B)(6), 2014 AFTER SUSTAINING A HEAD TRAUMA. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447916 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. | MCM | MCM | COCHLEAR LTD. | CI24RE (CA) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |