BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMB 40+

    MDR report key: 1022068 · Received March 27, 2008

    Report

    Report Number
    MW5006070
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    June 7, 2007
    Report Date
    March 27, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERATE GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEAR SIR/MADAM WITH DUE HOPES, I AM SUBMITTING MY CASE FOR YOUR KIND AND SERIOUS CONSIDERATION. MY SON IS A BORN DEAF CHILD, AND AFTER CONCERNING WITH VARIOUS CONSULTANTS, I GOT TO KNOW ABOUT MEDEL COMPANY'S MADE EQUIPMENT IS THE BEST SOLUTION FOR IT. AFTER MEETING WITH AUTHORIZED AND CONCERNED PERSONS OF MEDEL COMPANY, I DECIDED TO GET MY SON OPERATED FOR IMPLANTATION OF C40+ DEVICE AND TO DO SO FIRSTLY, FIRST OPERATION WAS DONE IN 2006 AT THE HOSPITAL AND CONDUCTED BY DR FROM ANOTHER COUNTRY THROUGH ARRANGEMENT BY DR AUTHORIZED PERSON FOR MED-EL COMPANY'S COCHLEAR IMPLANT DEVICES, THE DEVICE KEPT OPERATING TILL 2007, AND THEN STOPPED FUNCTIONING AND UPON CONSULTING WITH DR, AUTHORIZED PERSON, I WAS SUGGESTED TO GO FOR RE-IMPLANTATION OF MY SON AND AFTER MY APPROVAL, SECOND OPERATION WAS DONE ON APPROX TWO MONTHS LATER AT ANOTHER HOSPITAL. THIS TIME, PULSAR CI WAS INSTALLED IN REPLACEMENT OF C40+ DEVICE. NOW AGAIN THE DEVICE STOPPED FUNCTIONING SINCE 2008. NOW AGAIN, I AM BEING ADVISED TO GO FOR REVISION SURGERY, WHICH HAS LED ME AND MY FAMILY IN BIG CONFUSION AND STRESS. I WAS NOT INFORMED ABOUT THE LIKELINESS OF OCCURRENCE OF CONSEQUENCES AFTER THE INSTALLATION OF DEVICE RATHER I WAS MOTIVATED BY SAYING THAT MY SON'S AGE IS AN IDEAL AGE FOR INSTALLATION OF THIS DEVICE AND FAILURES ARE VERY RARE UP TO NEGLIGIBLE RATE. WOULD IT BE SAFE FOR MY SON TO GO FOR ANOTHER REVISION SURGERY? WE ARE DISSATISFIED WITH LOCAL & INTERNATIONAL AUTHORIZED MANAGEMENT OF MED-EL COMPANY AS NEITHER GIVE PROPER INFO NOR ASSIST PROPERLY TO SOLVE THE PROBLEM. STILL THEY ARE EMPHASIZING US TO GO FOR REVISION IMPLANTATION WITHOUT TAKING US IN CONFIDENCE BY EXPLAINING THE CONSEQUENCES FOR 3RD TIME RE-IMPLANTATION OF A CHILD. MY FAMILY AND I ARE IN DEEP STRESS AND TENSION NOW-A-DAYS. IT WOULD BE APPRECIATED IF YOU WOULD HELP US IN THIS REGARD AND SEND US YOUR RESEARCH REGARDING THIS MATTER. WE HOPE YOU WILL SERIOUSLY LOOK INTO THE MATTER AND SOLVE MY SERIOUS PROBLEM. DATES OF USE: 2006-2008, 8 MOS. DIAGNOSIS OR REASON FOR USE: DEAF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMB 40+ PULSAR MCM MED-EL ELEKTROMEDIZINISCHE GERATE GMBH PULSAR CI

    Patients

    Seq Age Sex Outcome Treatment
    1 26 MO Congenital Anomaly