FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
MDR report key: 6371052
·
Received March 1, 2017
Report
- Report Number
- 6000034-2017-00451
- Event Type
- Injury
- Date Received
- March 1, 2017
- Report Date
- March 20, 2017
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502032599
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON MARCH 02, 2017, BY COCHLEAR LIMITED ON BEHALF OF (B)(4) EXEMPTION NUMBER E2016011.
Description of Event or Problem · 0
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND MAGNET DISLODGEMENT DURING AN MRI (TESLA UNKNOWN). REVISION SURGERY TO REPOSITION THE MAGNET IS SCHEDULED; HOWEVER, IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT, MARCH 02, 2017.
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANAESTHESIA AND UNDERWENT REVISION SURGERY ON (B)(6) 2017, TO REPLACE MAGNET. THIS REPORT IS FILED ON APRIL 04, 2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 150489 | NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI522 | N/A | 09321502032599 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |