FDA Adverse Event
Injury
Summary report: N
NUCLEUS 22
MDR report key: 11683869
·
Received April 19, 2021
Report
- Report Number
- 6000034-2021-01015
- Event Type
- Injury
- Date Received
- April 19, 2021
- Date of Event
- March 22, 2021
- Report Date
- June 29, 2021
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- P890027
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE ANALYSIS REPORT IS ATTACHED. THIS REPORT IS SUBMITTED ON JULY 19, 2021.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON APRIL 19, 2021.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT WITH THE DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2021, AND THE PATIENT WAS IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 586499 | NUCLEUS 22 | NUCLEUS 22 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI22M | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |