FDA Adverse Event
Injury
Summary report: N
NUCLEUS HYBRID L24
MDR report key: 6172773
·
Received December 13, 2016
Report
- Report Number
- 6000034-2016-02524
- Event Type
- Injury
- Date Received
- December 13, 2016
- Date of Event
- December 7, 2016
- Report Date
- February 21, 2017
- Manufacturer
- COCHLEAR LTD
- Product Code
- PGQ
- UDI-DI
- 09321502012089
- PMA / PMN Number
- P130016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON DECEMBER 14, 2016, BY COCHLEAR LIMITED ON BEHALF OF (B)(4). EXEMPTION NUMBER E2016011.
Description of Event or Problem · 0
PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH DEVICE USE AND A SUBSEQUENT REDUCTION IN CLINICAL BENEFIT, RESULTING IN THE DECISION TO EXPLANT. THE DEVICE WAS EXPLANTED ON (B)(6) 2016, AND THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED ON MARCH 03, 2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 820591 | NUCLEUS HYBRID L24 | NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM | PGQ | COCHLEAR LTD | CI24RE (L24) | N/A | 09321502012089 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |