HIRES¿ ULTRA IMPLANT
Report
- Report Number
- 3006556115-2023-01923
- Event Type
- Malfunction
- Date Received
- October 27, 2023
- Date of Event
- October 7, 2025
- Report Date
- October 24, 2023
- Manufacturer
- ADVANCED BIONICS, LLC
- Product Code
- MCM
- UDI-DI
- 07630016841002
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.
ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE RECIPIENT WILL REPORTEDLY NOT PURSUE REVISION SURGERY AT THIS TIME. THE RECIPIENT CONTINUES TO USE THE DEVICE AND WILL BE MANAGED BY THE FACILITY. 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.
ADDITIONAL INFORMATION: SECTIONS B.3, D.6B, D.9 & H.6. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS RE-IMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. THE EXPLANTED DEVICE WAS RECEIVED BY ADVANCED BIONICS OCTOBER 28, 2025. ADVANCED BIONICS IS CURRENTLY ATTEMPTING TO OBTAIN CONSENT FROM THE RECIPIENT. THE DEVICE REMAINS INTACT IN A LOCKED VAULT AT AB, LLC UNTIL CONSENT IS OBTAINED. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.
A REVIEW OF THE RECIPIENT'S TEST DATA INDICATES IMPEDANCE ISSUES. REVISION SURGERY IS UNDER CONSIDERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1434253 | HIRES¿ ULTRA IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS, LLC | CI-1600-04 | NA | 07630016841002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |