FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
MDR report key: 8953007
·
Received September 1, 2019
Report
- Report Number
- 6000034-2019-01667
- Event Type
- Injury
- Date Received
- September 1, 2019
- Date of Event
- August 7, 2019
- Report Date
- September 13, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502032599
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED SEPTEMBER 27, 2019. - ATTACHMENT: [151947 DEVICE ANALYSIS REPORT REG.PDF].
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON SEPTEMBER 2, 2019.
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2019, DUE TO IMPROPER PLACEMENT OF THE ELECTRODE ARRAY DURING INITIAL SURGERY, RESULTING IN POOR PERFORMANCE. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 746873 | NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI522 | NA | 09321502032599 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |