Device product
MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f. Mi1000 CONCERTO PIN +Standard; g. M11000 CONCERTO +Compressed Product Usage: The Mi1000 CONCERTO Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.
Z-2136-2019
Product summary
- Event
- Event 81683
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 devices
- Official record key
device-enforcement:Z-2136-2019
Official wording
Reason: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Code information: a. Mil000 CONCERTO PIN +FLEX28, Serial Number 510312; b. Mi1000 CONCERTO +FLEX28, Serial Number 518214; c. Mi1000 CONCERTO PIN +FLEXsoft, Serial Number 531793; d. Mil000 CONCERTO +Standard, Serial Number 510079; e. Mil000 CONCERTO +Medium, Serial Number 532046; f. Mi1000 CONCERTO PIN +Standard, Serial Number 535616; g. M11000 CONCERTO +Compressed, Serial Number 538434
Distribution pattern: Worldwide distribution - US Nationwide in the states of California and Illinois. Countries of ARGENTINA, AUSTRALIA, AUSTRIA, BRAZIL, BULGARIA, CHINA, FRANCE, GEORGIA, KOREA, REPUBLIC OF, POLAND, RUSSIAN FEDERATION, SPAIN, SWEDEN.
Derived failure modes
-
Unknown
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.