BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUCLUES 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 640835 · Received October 17, 2005

    Report

    Report Number
    6000034-2005-00314
    Event Type
    Death
    Date Received
    October 17, 2005
    Date of Event
    June 1, 2005
    Report Date
    October 17, 2005
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED ON 10/21/2005 FROM THE IMPLANT SURGEON INDICATED THAT THE PATIENT HAD BILATERAL VP SHUNTS AND VENTRICULTOMY FOR DRAINAGE OF HYDROCOPHALUS FLUID (NO DATES GIVEN). THE IMPLANT SURGEON ALSO NOTED THAT THE LEFT SHUNT WAS BLOCKED AT THE TIME OF THE IMPLANT SURGERY. AT SOME POINT FOLLOWING IMPLANT SURGERY (NO DATE GIVEN), THE RIGHT SHUNT BECAME BLOCKED. THE PATIENT WAS ADMITTED TO THE HOSPITAL BY THE NEUROSURGEON. A VENTRICULTOMY WITH IMPLANTATION OF A RESERVOIR WAS DONE. TREATMENT INCLUDED DAILY ASPIRATION. PER THE IMPLANT SURGEON, "THIS LED TO BRAIN INFECTION AND IT IS UNLIKELY THAT THE CHILD GOT INFECTED DUE TO CI" (COCHLEAR IMPLANT). THE SURGEON ALSO STATED THAT THE FACT THAT THIS CHILD WAS CONSIDERED AT HIGH RISK OF SERIOUS COMPLICATIONS WAS EXPLAINED TO THE PARENTS PRIOR TO IMPLANT SURGERY. A MEDICAL HISTORY AND QUESTIONNAIRE ARE REPORTEDLY BEING PREPARED BY THE HEALTHCARE PROVIDERS INVOLVED WITH THE CHILD'S MEDICAL CARE.

    Description of Event or Problem · 1

    IN 2005, COCHLEAR AMERICAS WAS NOTIFIED OF A MENINGITIS DEATH. REPORTEDLY, THIS PT PRESENTED WITH A HISTORY OF HYDROCEPHALUS AND CONTRACTED MENINGITIS IMMEDIATELY FOLLOWING COCHLEAR IMPLANT SURGERY FOUR MONTHS EARLIER. HE WAS TREATED WITH ANTIBIOTICS, BUT EXPIRED AFTER A THREE-MONTH ILLNESS ABOUT THREE MONTHS LATER. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE DR (I.E., INFECTIVE ORGANISM, A COMPLETE HISTORY OF THE PATIENT'S ILLNESS AND TREATMENT, IMMUNIZATION STATUS AND PREOPERATIVE RISK FACTORS) AND WILL BE REPORTED TO FDA, WHEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLUES 24 CHANNEL COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM COCHLEAR LTD. C124M *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death