FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1033714
·
Received April 25, 2008
Report
- Report Number
- 6000034-2008-00214
- Event Type
- Injury
- Date Received
- April 25, 2008
- Date of Event
- October 31, 2007
- Report Date
- April 25, 2008
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.
Description of Event or Problem · 1
PER THE AUDIOLOGIST, THE PT WAS HIT IN THE HEAD AT SCHOOL. SINCE THAT TIME THE PT HAS REPORTED A LOW BUZZING SOUND WITH AND WITHOUT DEVICE USE. EXCHANGING EXTERNAL EQUIPMENT DID NOT ALLEVIATE THE PROBLEM. RESULTS OF AN INTEGRITY TEST DONE IN 2007 SHOWED NORMAL RECEIVER/STIMULATOR FUNCTION. THE PT'S SOUND PROCESSOR WAS REPROGRAMMED AND SHE WAS MONITORED CLOSELY FOR ANY CHANGES. ON THREE WEEKS LATER, THE PT'S MOTHER REPORTED THAT THE NOISE HAD GOTTEN LOUDER. THE SURGEON PRESCRIBED THREE WEEKS OF STEROID TREATMENT FOR A SUSPECTED EUSTACHIAN TUBE DYSFUNCTION. THE PT'S DEVICE WAS EXPLANTED IN 2008 AND A NEW DEVICE WAS REIMPLANTED DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | COCHLEAR LTD. | CI24M | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |