FDA Adverse Event
Injury
Summary report: N
COCHLEAR OSIA OSI200 IMPLANT
MDR report key: 10262274
·
Received July 12, 2020
Report
- Report Number
- 6000034-2020-01861
- Event Type
- Injury
- Date Received
- July 12, 2020
- Date of Event
- June 25, 2020
- Report Date
- October 20, 2020
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- MCM
- UDI-DI
- 09321502046152
- PMA / PMN Number
- K190589
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE ANALYSIS REPORT IS ATTACHED. THIS REPORT IS SUBMITTED ON NOVEMBER 13, 2020.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON JULY 13 2020.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED PERSISTENT STATIC SINCE ACTIVATION. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED (B)(6) 2020. REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT, (B)(6) 2020.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726289 | COCHLEAR OSIA OSI200 IMPLANT | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR BONE ANCHORED SOLUTIONS AB | OSI200 | NA | 09321502046152 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Required Intervention |