HIRES¿ ULTRA 3D IMPLANT
Report
- Report Number
- 3006556115-2025-00975
- Event Type
- Death
- Date Received
- July 21, 2025
- Report Date
- June 30, 2025
- Manufacturer
- ADVANCED BIONICS, LLC
- Product Code
- MCM
- UDI-DI
- 00840094456020
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.
THE RECIPIENT WAS REPORTEDLY ADMITTED TO THE HOSPITAL ON (B)(6) 2025. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.
ADDITIONAL INFORMATION: SECTION A.1, A.2, A.3, D.1, D.4, D.5, D.6A, D.6B, H.4, H.10. ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE RECIPIENT REPORTEDLY PASSED AWAY. THE RECIPIENT'S DEATH WAS NOT DEVICE RELATED. NO FURTHER DETAILS WILL BE PROVIDED. THIS IS THE FINAL REPORT. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.
THE RECIPIENT IS REPORTEDLY EXPERIENCING DIZZINESS, LOW OXYGEN AND NAUSEA FOLLOWING INITIAL IMPLANT SURGERY. THE RECIPIENT WAS REPORTEDLY PRESCRIBED MEDICATION (TYPE UNKNOWN). ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2036456 | HIRES¿ ULTRA 3D IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS, LLC | CI-1601-05 | NA | 00840094456020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Hospitalization| R |