BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3930053 · Received March 10, 2014

    Report

    Report Number
    9710014-2014-00118
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    February 15, 2014
    Report Date
    February 27, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO 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 PATIENT, IMPLANTED IN 2001, EXPERIENCED 6 EPISODES OF WHAT WAS REPORTED AS 'ELECTRIC DISCHARGES IN HIS EAR', WHILST USING THE AUDIO PROCESSOR, BETWEEN (B)(4) 2014. THE PATIENT HAD TO TAKE OFF THE AUDIO PROCESSOR. ALL EXTERNAL COMPONENTS WERE EXCHANGED AND THE PATIENT DID NOT REPORT YET ANY NEW EPISODES WITH THE NEW EXTERNAL DEVICE. PER INFORMATION RECEIVED ON (B)(6) 2014, IT WAS DECIDED THAT THE PATIENT WILL BE RE-IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143804 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR