BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1082293 · Received July 29, 2008

    Report

    Report Number
    9710014-2008-00231
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 9, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINIC HAD EXPRESSED CONCERN IN FEBRUARY 2008, OVER THE PRESENCE OF ONE HI ELECTRODE CHANNEL AND ONE PAIR OF SHORT CIRCUITED CHANNELS. IN ADDITION, THERE WAS THE APPEARANCE OF SEVERAL CHANNELS SHOWING >. THE FATHER OF THE PATIENT REPORTED A DECREASE IN THE RATE OF INCREASED LEVEL OF PERFORMANCE BY THE PATIENT. THE CLINIC WILL ENSURE THAT CHANNELS 2, 3 AND 4 ARE TURNED OFF IN THE PATIENT'S MAP. AN E.MAIL FROM REP OF MED-EL CORP WAS RECEIVED ON MARCH 20, 2008 STATING THAT SHE HAD FINALLY HEARD BACK FROM THE AUDIOLOGIST HANDLING THE CASE. SHE HAD NO FURTHER NEWS ON THE PATIENT, BUT PROMISED TO HAVE HER SECRETARY CALL THE FAMILY FOR FOLLOW-UP. A FURTHER E.MAIL FROM REP RECEIVED ON APRIL 16, STATED THAT FROM WHAT SHE UNDERSTOOD, AT THIS POINT, NO FURTHER ACTION WILL BE TAKEN OTHER THAN MONITORING. THE COMPLAINT WAS CLOSED IN 2008. THE COMPLAINT WAS RE-OPENED UPON RECEIPT OF THE INFORMATION THAT THE PATIENT HAS NOW BEEN RE-IMPLANTED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH C40+

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention