FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CONTOUR
MDR report key: 9096173
·
Received September 19, 2019
Report
- Report Number
- 6000034-2019-01900
- Event Type
- Malfunction
- Date Received
- September 19, 2019
- Date of Event
- June 26, 2019
- Report Date
- October 2, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
ANALYSIS OF THE DEVICE ON RETURN TO COCHLEAR WAS A DEVICE FAILURE. THIS REPORT IS SUBMITTED 25 OCTOBER 2019. - ATTACHMENT: [153246 DEVICE ANALYSIS REPORT.PDF].
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON SEPTEMBER 20, 2019.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH DEVICE USE; SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2019 AND THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 889552 | NUCLEUS 24 CONTOUR | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI24R(CS) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Required Intervention |