FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2801824
·
Received October 23, 2012
Report
- Report Number
- 6000034-2012-01972
- Event Type
- Injury
- Date Received
- October 23, 2012
- Date of Event
- January 12, 2010
- Report Date
- July 11, 2013
- Manufacturer
- COCHLEAR LTD .
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE PATIENT WAS EXPLANTED (B)(6) 2013. THIS REPORT FILED SEPTEMBER 23, 2013.
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THIS PATIENT HAD NO BEHAVIORAL RESPONSE TO ELECTRICAL STIMULATION AT MAXIMUM PROGRAMMING PARAMETERS SINCE ACTIVATION WITH THE DEVICE. AN INTEGRITY TEST WAS CONDUCTED IN THE OPERATING ROOM UNDER ANESTHESIA TO RULE OUT A MALFUNCTION OF THE RECEIVER/ STIMULATOR USING THE CRYSTAL INTEGRITY TEST SYSTEM DUE TO THIS OUTCOME OF NO RESPONSE TO STIMULATION. ADDITIONALLY, TESTING WAS UNDERTAKEN TO DETERMINE IF THERE WERE ANY PHYSIOLOGIC RESPONSES (AUDITORY BRAINSTEM RESPONSES). BASED UPON LAST FOLLOW UP FROM THE CLINIC THE PATIENT CONTINUES TO WEAR THE SOUND PROCESSOR AND THE INTERNAL DEVICE REMAINS IN SITU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD . | CI512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 MO | Required Intervention |