FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 10060136
·
Received May 15, 2020
Report
- Report Number
- 6000034-2020-01396
- Event Type
- Injury
- Date Received
- May 15, 2020
- Date of Event
- September 29, 2018
- Report Date
- July 21, 2020
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502007320
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
THE DATE OF AWARENESS WAS 29 SEP 2018. THIS REPORT IS SUBMITTED ON MAY 15, 2020.
Additional Manufacturer Narrative · 0
THE DEVICE ANALYSIS REPORT IS ATTACHED. THIS REPORT IS SUBMITTED ON AUGUST 14, 2020. (B)(4).
Additional Manufacturer Narrative · 0
THE DATE OF AWARENESS WAS SEP 29, 2019. THIS REPORT IS SUBMITTED ON MAY 15, 2020.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON MAY 15, 2020.
Description of Event or Problem · 1
PER THE CLINICIAN, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2018 AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE (COMPETITOR'S DEVICE) DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 526967 | NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI24RE(CA) | N/A | 09321502007320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |