FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 10268842
·
Received July 13, 2020
Report
- Report Number
- 6000034-2020-00986
- Event Type
- Injury
- Date Received
- July 13, 2020
- Date of Event
- March 13, 2020
- Report Date
- October 20, 2020
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502014564
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PER THE CLINIC, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2020, AND THE PATIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY. THIS REPORT IS SUBMITTED JULY 14, 2020.
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON 26 OCT 2020.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON JULY 14, 2020.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS. IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726709 | NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI512 | NA | 09321502014564 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Required Intervention |