FDA Adverse Event
Injury
Summary report: N
NUCLEUS HYBRID L24
MDR report key: 8751448
·
Received July 1, 2019
Report
- Report Number
- 6000034-2019-01042
- Event Type
- Injury
- Date Received
- July 1, 2019
- Date of Event
- June 7, 2019
- Report Date
- August 6, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- PGQ
- UDI-DI
- 09321502012089
- PMA / PMN Number
- P130016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED SEPTEMBER 02, 2019.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON JULY 02, 2019.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. THE DEVICE WAS EXPLANTED (B)(6) 2019 AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 545012 | NUCLEUS HYBRID L24 | NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM | PGQ | COCHLEAR LTD | CI24RE (L24) | N/A | 09321502012089 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Required Intervention |