FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
MDR report key: 5536969
·
Received March 30, 2016
Report
- Report Number
- 6000034-2016-00627
- Event Type
- Injury
- Date Received
- March 30, 2016
- Date of Event
- March 10, 2016
- Report Date
- May 25, 2016
- Manufacturer
- COCHLEAR LTD .
- Product Code
- PGQ
- PMA / PMN Number
- 130016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED MARCH 30, 2016. THE DEVICE IS CURRENTLY UNAVAILABLE.
Additional Manufacturer Narrative · 1
CORRECTION: THE CORRECT COMMON DEVICE NAME IS PGQ, NOT MCM AS PREVIOUSLY REPORTED.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. SUBSEQUENTLY ON (B)(6) 2016, THE DEVICE WAS EXPLANTED AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, MARCH 30, 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189703 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. | PGQ: PRODUCT CODE: | PGQ | COCHLEAR LTD . | CI24RE (L24) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |