FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 5832253
·
Received July 29, 2016
Report
- Report Number
- 6000034-2016-01577
- Event Type
- Injury
- Date Received
- July 29, 2016
- Date of Event
- July 19, 2016
- Report Date
- August 26, 2016
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED BY COCHLEAR LIMITED (MANUFACTURER) ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. THIS REPORT IS FILED AUGUST 30, 2016. (B)(4).
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED BY COCHLEAR LIMITED (MANUFACTURER) ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. THIS REPORT IS FILED ON JULY 29, 2016. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem · 0
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND HEADACHES WITH DEVICE USE AND A SUBSEQUENT REDUCTION IN CLINICAL BENEFIT, RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED (B)(6) 2016. THE PATIENT WAS RE-IMPLANTED WITH ANOTHER MANUFACTURER'S DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 486330 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | CI24R(ST) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention |