CI-1500-01
Report
- Report Number
- 3006556115-2025-01209
- Event Type
- Injury
- Date Received
- September 9, 2025
- Report Date
- August 19, 2025
- Manufacturer
- ADVANCED BIONICS, LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: SECTION H.4 & D.4. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.
DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.
ADDITIONAL INFORMATION: SECTION D.6B. ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE REVISION SURGERY HAS BEEN POSTPONED INDEFINITELY. THE RECIPIENT IS REPORTEDLY WEARING THE DEVICE. ADDITIONAL INFORMATION REGARDING TREATMENT DETAILS WERE NOT 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 REPORTEDLY ELECTED REVISION FOR A TECHNOLOGY UPGRADE. REVISION SURGERY IS SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2501448 | CI-1500-01 | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS, LLC | HIRES 90K¿ ADVANTAGE IMPLANT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |