FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24
MDR report key: 13717901
·
Received March 10, 2022
Report
- Report Number
- 6000034-2022-00708
- Event Type
- Malfunction
- Date Received
- March 10, 2022
- Date of Event
- February 21, 2022
- Report Date
- October 19, 2022
- Manufacturer
- COCHLEAR LIMITED
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON MARCH 10, 2022.
Additional Manufacturer Narrative · 0
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2022 AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THIS REPORT IS SUBMITTED ON JUNE 09, 2022.
Additional Manufacturer Narrative · 0
DEVICE ANALYSIS REPORT ATTACHED. THIS REPORT IS SUBMITTED ON NOVEMBER 09, 2022.
Description of Event or Problem · 0
PER THE CLINIC, THE PATIENT EXPERIENCED LOSS OF CONNECTION TO THE INTERNAL DEVICE. TROUBLESHOOTING ATTEMPTS WERE MADE. HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH A NEW DEVICE; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1623737 | NUCLEUS 24 | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LIMITED | CI24M | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Male | Other| R |