FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3132288
·
Received May 29, 2013
Report
- Report Number
- 6000034-2013-00986
- Event Type
- Injury
- Date Received
- May 29, 2013
- Date of Event
- May 16, 2013
- Report Date
- July 5, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CORRECTION: THE BATTERY HAD A BROKEN TAB; IT DID NOT OVERHEAT AS PREVIOUSLY REPORTED. THIS REPORT IS FILED SEPTEMBER 25, 2013.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT REPORTED THAT THE RECHARGEABLE BATTERY OVERHEATED. THE DEVICE WAS REQUESTED TO BE REMOVED FROM SERVICE AND A REPLACEMENT BATTERY WAS SHIPPED TO THE PATIENT. THERE ARE NO ALLEGATIONS OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236310 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | SP12 ACCESSORY | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |