BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1050258 · Received May 22, 2008

    Report

    Report Number
    6000034-2008-00270
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    January 21, 2008
    Report Date
    July 13, 2010
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Additional Manufacturer Narrative · 1

    PER THE PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B) (6) 2010, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME SURGERY.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, AFTER THE SURGERY, THE PATIENT REMAINED HOSPITALIZED FOR FOUR DAYS DUE TO SEVERE DIZZINESS. HE STILL HAS SOME IMBALANCE AND UNSTEADINESS WHEN WALKING. RESULTS OF AN INTEGRITY TEST DONE IN 2008 SUGGESTED NORMAL RECEIVER/STIMULATOR FUNCTION. THERE HAS BEEN NO X-RAY OR CT SCAN DONE BUT TESTING AT THE CLINIC SUGGESTS THE POSSIBILITY THAT THE ELECTRODE ARRAY IS NOT FULLY INSERTED INTO THE COCHLEA. REPROGRAMMING HAS BEEN RECOMMENDED.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT¿S FIXTURE EXTRUDED AND FELL OUT. INFORMATION ON REIMPLANTATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THEY OBSERVED A CRACK IN THEIR FREESTYLE NAVIGATOR TRANSMITTER. IT HAS BEEN DETERMINED THAT SOME FREESTYLE NAVIGATOR TRANSMITTERS COULD POTENTIALLY EXHIBIT A CRACK/FRACTURE ON THE PLASTIC HOUSING NEAR THE BATTERY COMPARTMENT, WHICH COULD POTENTIALLY ALLOW MOISTURE TO COME IN CONTACT WITH THE TRANSMITTER'S INTERNAL ELECTRONICS, POTENTIALLY CAUSING THE TRANSMITTER AND THE RECEIVER TO LOSE CONNECTION INTERRUPTING THE CONTINUOUS GLUCOSE RESULTS. ALTHOUGH UNLIKELY, MOISTURE ENTERING THE TRANSMITTER HAS THE POTENTIAL TO GENERATE INACCURATE RESULTS ONLY WITH THE CONTINUOUS GLUCOSE READINGS. THE BUILT-IN FREESTYLE GLUCOSE METER IS NOT IMPACTED BY THIS ISSUE AND THE USER CAN CONTINUE TO USE THE BUILT-IN METER. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention