BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3903401 · Received June 30, 2014

    Report

    Report Number
    6000034-2014-00916
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, NO CONNECTION COULD BE MADE TO THE INTERNAL DEVICE, AND THE ISSUE COULD NOT BE RESOLVED. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2014; DURING THE SAME SURGERY, THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE. BASED ON CLINICAL SYMPTOMS AND REMOTE TROUBLESHOOTING PERFORMED ON (B)(6) 2014, IT WAS DETERMINED THAT A MALFUNCTION OF THE RECEIVER STIMULATOR HAS OCCURRED. CORRECTION: DATE OF EVENT IS (B)(6) 2014; NOT JUNE 6, 2014 AS PREVIOUSLY REPORTED. CORRECTION: DATE OF THIS REPORT IS (B)(4) 2014, NOT JUNE 6, 2014 AS PREVIOUSLY REPORTED. CORRECTION: THE PATIENT WAS NOT ADMINISTERED CHLORAL HYDRATE ORAL SEDATION ON (B)(6) 2014 TO FACILITATE AN INTEGRITY TEST AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT SERIAL NUMBER IS (B)(4); NOT 1020120200370 AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT DATE OF IMPLANT IS (B)(6) 2010; NOT JUNE 9, 2010 AS PREVIOUSLY REPORTED. CORRECTION: THE INITIAL REPORTER WAS (B)(6); NOT ALYSON MELLISH AT RADY CHILDRENS HOSPITAL AS PREVIOUSLY REPORTED. CORRECTION: THE TYPE OF REPORTABLE EVENT IS A MALFUNCTION; NOT A SERIOUS INJURY AS PREVIOUSLY REPORTED. (B)(4). THIS REPORT IS FILED OCTOBER 2, 2014. DEVICE CURRENTLY UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS ADMINISTERED CHLORAL HYDRATE ORAL SEDATION ON (B)(6), 2014 TO FACILITATE INTEGRITY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379869 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM COCHLEAR LTD . CI512

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention