FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24
MDR report key: 10446663
·
Received August 24, 2020
Report
- Report Number
- 6000034-2020-02211
- Event Type
- Malfunction
- Date Received
- August 24, 2020
- Date of Event
- August 3, 2020
- Report Date
- November 24, 2020
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON DECEMBER 14, 2020.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON AUGUST 25, 2020.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES WITH DEVICE USE. THE DEVICE WAS EXPLANTED ON (B)(6) 2020, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 905408 | NUCLEUS 24 | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI24M | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Required Intervention |