BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2971335 · Received September 21, 2007

    Report

    Report Number
    6000034-2007-00586
    Event Type
    Injury
    Date Received
    September 21, 2007
    Date of Event
    July 31, 2007
    Report Date
    September 21, 2007
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS ALSO DOCUMENTED THROUGH A MEDWATCH REPORT, (B)(4). (B)(4) - THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE PHYSICIAN'S REPORT, THIS PATIENT PRESENTED TO THE HOSPITAL APPROXIMATELY ONE YEAR POST-OPERATIVELY WITH MENINGITIS. THE PATIENT'S SYMPTOMS INCLUDED FEVER, EAR PAIN, HEADACHE, NAUSEA AND VOMITING. A LUMBAR PUNCTURE WAS COMPLETED, BUT THE RESULTS WERE NOT PROVIDED. THE PHYSICIAN TREATED THE PATIENT WITH IV VANCOMYCIN AND CEFTRIAXONE. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN AND WILL BE PROVIDED AS SOON AS IT BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L