BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1111030 · Received August 12, 2008

    Report

    Report Number
    6000034-2008-00438
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    May 22, 2007
    Report Date
    February 29, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT, FILED ON AUGUST 12, 2008.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PT HAD NO MEASURABLE SPEECH DISCRIMINATION PRIOR TO COCHLEAR IMPLANT SURGERY. AFTER HER COCHLEAR IMPLANT SYS WAS ACTIVATED, THE PT REPORTED THAT SHE HEARD "NOTHING". AFTER FURTHER SOUND PROCESSOR PROGRAMMING THE PT WAS ABLE TO HEAR SOME SOUNDS BUT DID NOT DERIVE BENEFIT FROM THE COCHLEAR IMPLANT SYS. A CT SCAN WAS DONE (DATE NOT REPORTED). A REVIEW OF THE SCAN SHOWED THAT THE ELECTRODE ARRAY WAS "BUCKLED" ON ITSELF IN THE BASAL PORTION OF THE COCHLEA. THE DEVICE WAS EXPLANTED IN 2008 AND THE PT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THREE MONTHS LATER, THE PT REPORTS RECEIVING NO BENEFIT FROM THE NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. CI24RE(CA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention