FDA Adverse Event
Malfunction
Summary report: N
NUCLEUSCI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 8498133
·
Received April 9, 2019
Report
- Report Number
- 6000034-2019-00601
- Event Type
- Malfunction
- Date Received
- April 9, 2019
- Date of Event
- March 21, 2019
- Report Date
- May 28, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502007320
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
ANALYSIS OF DEVICE INDICATES A DEVICE FAILURE. THIS REPORT IS FILED ON JUNE 24, 2019. - ATTACHMENT: [140728 DEVICE ANALYSIS REPORT.PDF].
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON APRIL 10, 2019.
Description of Event or Problem · 1
PER THE PATIENT'S SURGEON, THE PATIENT ELECTED TO HAVE THE DEVICE EXPLANTED ON (B)(6) 2019 DUE TO POOR PERFORMANCE AND LACK OF CLINICAL BENEFIT WITH DEVICE. THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291357 | NUCLEUSCI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI24RE(CA) | N/A | 09321502007320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |