FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
MDR report key: 5059806
·
Received September 8, 2015
Report
- Report Number
- 6000034-2015-01807
- Event Type
- Injury
- Date Received
- September 8, 2015
- Date of Event
- August 10, 2015
- Report Date
- January 29, 2016
- Manufacturer
- COCHLEAR LTD .
- Product Code
- MHE
- PMA / PMN Number
- 000015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS CURRENTLY UNAVAILABLE.
Additional Manufacturer Narrative · 1
CORRECTION: THE CORRECT COMMON DEVICE NAME IS MHE, NOT MCM AS PREVIOUSLY REPORTED.
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2015 DUE TO TUMOR RESECTION NECESSARY FOR MULTIPLE LARGE TUMORS. DURING THE SAME PROCEDURE THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, (B)(4) 2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 593813 | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM | MHE, PRODUCT CODE: | MHE | COCHLEAR LTD . | ABI24M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Required Intervention |