FDA Adverse Event
Injury
Summary report: N
COCHLEAR OSIA OSI200 IMPLANT
MDR report key: 19534542
·
Received June 13, 2024
Report
- Report Number
- 6000034-2024-02117
- Event Type
- Injury
- Date Received
- June 13, 2024
- Date of Event
- May 14, 2024
- Report Date
- February 14, 2025
- Manufacturer
- COCHLEAR LIMITED
- Product Code
- PFO
- UDI-DI
- 09321502046152
- PMA / PMN Number
- K191921
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
CORRECTION: THE INITIAL MDR SUBMITTED ON JUNE 14, 2024 WAS FILED INADVERTENTLY. NO DEVICE MALFUNCTION OR SERIOUS INJURY HAS OCCURRED. THERE BEING A "NATURAL" PROGRESSION OF THE HEARING LOSS THAT RESULTS IN THE OSIA NO LONGER MEETING THE RECIPIENT'S HEARING REQUIREMENT. THIS IS CONSIDERED THE INITIAL IMPLANTATION OF THE CI DEVICE AND THEREFORE NOT REPORTABLE.
Additional Manufacturer Narrative · 0
DEVICE ANALYSIS REPORT ATTACHED.
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON JUNE 14, 2024.
Description of Event or Problem · 0
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2024 DUE TO PERFORMANCE DECLINE WITH THE DEVICE. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157683 | COCHLEAR OSIA OSI200 IMPLANT | COCHLEAR¿ OSIA¿ SYSTEM | PFO | COCHLEAR LIMITED | OSI200 | NA | 09321502046152 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Female | Required Intervention |