FDA Adverse Event
Injury
Summary report: N
NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE
MDR report key: 9121584
·
Received September 26, 2019
Report
- Report Number
- 6000034-2019-01918
- Event Type
- Injury
- Date Received
- September 26, 2019
- Report Date
- October 4, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502025683
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED OCTOBER 30, 2019. - ATTACHMENT: [153401 DEVICE ANALYSIS REPORT REG.PDF].
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON SEPTEMBER 26, 2019.
Description of Event or Problem · 1
PER THE PATIENT'S SURGEON, THE PATIENT'S DEVICE WAS EXPLANTED ON JULY 17, 2019 DUE TO INFECTION AT IMPLANT SITE. THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 917819 | NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI24RE (ST) | N/A | 09321502025683 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |