FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE
MDR report key: 10882062
·
Received November 22, 2020
Report
- Report Number
- 6000034-2020-03301
- Event Type
- Injury
- Date Received
- November 22, 2020
- Date of Event
- October 28, 2020
- Report Date
- December 4, 2020
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502036580
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE ANALYSIS REPORT IS ATTACHED. THIS REPORT IS SUBMITTED ON DECEMBER 23, 2020.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON NOVEMBER 23, 2020.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED WOUND BREAKDOWN AT THE IMPLANT SITE AND AN EXTRUSION OF THE RECEIVER/STIMULATOR THROUGH THE SKIN. THE DEVICE WAS EXPLANTED ON (B)(6) 2020. THE PATIENT HAS NOT BEEN REIMPLANTED WITH A NEW DEVICE AS OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1346879 | NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI632 | NA | 09321502036580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |