FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE
MDR report key: 15051136
·
Received July 19, 2022
Report
- Report Number
- 6000034-2022-02080
- Event Type
- Injury
- Date Received
- July 19, 2022
- Report Date
- July 29, 2022
- Manufacturer
- COCHLEAR LIMITED
- Product Code
- MCM
- UDI-DI
- 09321502036580
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON (B)(6) 2022.
Additional Manufacturer Narrative · 0
CORRECTION: THE PREVIOUS OR INITIAL MDR SUBMITTED ON JULY 19, 2022, WAS FILED INADVERTENTLY. NO DEVICE MALFUNCTION/ EXPLANTATION OR SERIOUS INJURY HAS OCCURRED. THIS REPORT IS SUBMITTED ON AUGUST 19, 2022.
Description of Event or Problem · 0
PER THE CLINIC, THE DEVICE WAS EXPLANTED (SPECIFIC DATE NOT REPORTED) DUE TO A TIP FOLDOVER. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE (SPECIFIC DATE NOT REPORTED).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1718230 | NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LIMITED | CI632 | NA | 09321502036580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |