FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
MDR report key: 8525617
·
Received April 17, 2019
Report
- Report Number
- 6000034-2019-00611
- Event Type
- Malfunction
- Date Received
- April 17, 2019
- Date of Event
- April 2, 2019
- Report Date
- May 7, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502032599
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON MAY 30, 2019. - ATTACHMENT: [140799 - DEVICE ANALYSIS REPORT REG.PDF].
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON APRIL 18, 2019.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED ZIG-ZAG IMPEDANCES AND OPEN CIRCUIT ELECTRODES. THE DEVICE WAS EXPLANTED (B)(6) 2019. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 318586 | 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 | 80 YR | Required Intervention |