BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1135893 · Received August 20, 2008

    Report

    Report Number
    6000034-2008-00469
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COCHLEAR LTD. HAS AN ONGOING INVESTIGATION INTO BATTERY FAULTS. THIS IS A FINAL REPORT, FILED ON AUGUST 20, 2008.

    Description of Event or Problem · 1

    PER THE PATIENT'S PARENT DURING A PHONE CALL IN 2008, THE RECHARGEABLE BATTERY FOR THE PATIENT'S SOUND PROCESSOR WAS "LEAKING FLUID" AND THAT THERE WAS A "FOUL ODOR" COMING FROM THE BATTERY/SOUND PROCESSOR. AFER REMOVING THE SOUND PROCESSOR, THE PATIENT'S SKIN WAS REPORTEDLY "RED, SORE, AND SWOLLEN" AT THE SITE WHERE THE SOUND PROCESSOR IS WORN. AT THE TIME THE PARENT CALLED, THE CHILD WAS ASLEEP FOR THE NIGHT. THE MANUFACTURER RECOMMENDED THAT THE PARENT DISCONTINUE USE OF THE RECHARGEABLE BATTERY AND SEEK MEDICAL CARE IF THE PATIENT'S SKIN DID NOT APPEAR IMPROVED IN THE MORNING. THE PARENT WAS CONTACTED BY THE MANUFACTURER THE FOLLOWING MORNING. THE PARENT REPORTED THAT THE PATIENT'S SKIN AT THE AFFECTED SITE WAS GREATLY IMPROVED. THE PARENT REPORTEDLY DID NOT THINK MEDICAL MANAGEMENT WAS NECESSARY. A SECOND FOLLOW-UP CALL WAS MADE TO THE PATIENT'S PARENT IN 2005. THE PARENT REPORTED THAT THE SITE WAS "ENTIRELY HEALED" AND THERE IS "NO SIGN WHATSOEVER" OF THE INCIDENT. A QUESTIONNAIRE ABOUT BATTERIES WAS EMAILED TO THE PARENT AND THE MANUFACTURER REQUESTED THAT THE PARENT RETURN THE BATTERIES AND BATTERY CHARGER FOR ANALYSIS. DESPITE MULTIPLE REQUESTS, THE BATTERIES AND CHARGER WERE NOT SENT TO THE MANUFACTURER. THE COMPLETED QUESTIONNAIRE WAS RECEIVED BY THE MANUFACTURER. THE INFORMATION WAS CONSISTENT WITH THE ABOVE, ADDING THAT THERE WAS NO HEAT PRODUCED BY THE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. Z60962 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR